1103 articles by Susan Kelly

• Masimo finds buyer for consumer audio business

  May 7, 2025

• US semiconductor import probe looms over medtech industry

  May 6, 2025

• Edwards gains expanded TAVR label for asymptomatic patients

  May 5, 2025

• GE Healthcare slashes 2025 profit forecast on tariff impact

  April 30, 2025

• 4 PFA studies in the spotlight at Heart Rhythm 2025

  April 29, 2025

• Medtronic submits Hugo soft tissue robot for FDA approval

  April 28, 2025

• Edwards shrugs off tariffs, backs 2025 profit forecast

  April 24, 2025

• Field Medical raises $40M for PFA in ventricular tachycardia

  April 23, 2025

• Intuitive lowers profit margin forecast due to tariff pressure

  April 23, 2025

• FDA issues early alert for BD catheters due to leaks

  April 21, 2025

• A judge blocked the FDA’s plan to regulate LDTs. What now?

  April 16, 2025

• J&J completes first surgeries with Ottava robot

  April 15, 2025

• Tariffs top of mind for medtech firms this earnings season

  April 14, 2025

• Tariff turmoil: Hospitals, device makers welcome pause, but fear long-term pain

  April 10, 2025

• Tariffs send healthcare industry into ‘unchartered waters’

  April 4, 2025

• AdvaMed repeats call for tariff exemption as new levies threaten healthcare supply chain

  April 3, 2025

• CMR Surgical secures $200M for US robot rollout

  April 2, 2025

• 3 takeaways from ACC 2025

  April 2, 2025

• Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

  April 1, 2025

• Abbott snags early CE mark for Volt PFA device

  March 28, 2025

• Why HCA is ‘all in’ on surgical robotics

  March 24, 2025

• Smiths Medical recalls port implants, warns on endotracheal tubes

  March 21, 2025

• Monogram robot wins FDA OK; Vicarious hit by supplier woes

  March 19, 2025

• J&J’s Monarch robot wins FDA nod for AI software update

  March 13, 2025

• Labcorp to buy Opko unit’s cancer test assets for up to $225M

  March 12, 2025

• Capstan brings surgical robot to valve replacement

  March 11, 2025

• Illumina’s DNA sequencers hit with China import ban

  March 6, 2025

• Staar Surgical names Stephen Farrell as CEO

  March 4, 2025

• Steven Mickelsen, Farapulse founder, eyes next frontier in pulsed field ablation

  March 4, 2025

• Illumina to lay off 96 San Diego employees

  Feb. 28, 2025

• Teleflex to split in 2, buy Biotronik assets for $791M among slew of actions

  Feb. 27, 2025

• Staar Surgical to lay off 115 people in California

  Feb. 26, 2025

• Thermo Fisher to buy Solventum’s purification and filtration unit for $4.1B

  Feb. 25, 2025

• Medtronic gains FDA OK for self-adjusting DBS system for Parkinson’s

  Feb. 24, 2025

• After tough year, Baxter looks for next CEO to drive growth

  Feb. 21, 2025

• Advamed CEO warns FDA job cuts put patients, industry at risk

  Feb. 19, 2025

• Vicarious Surgical COO John Mazzola to retire

  Feb. 19, 2025

• Edwards predicts second-half lift from TAVR label expansion

  Feb. 12, 2025

• How Trump’s trade fight could impact the medtech industry

  Feb. 12, 2025

• M&A and a separation take center stage in latest earnings season

  Feb. 10, 2025

• Thermo Fisher lays off another 300 workers in Massachusetts

  Feb. 7, 2025

• Illumina placed on China’s unreliable entity list

  Feb. 5, 2025

• FDA labels recall of discontinued Olympus endoscope part as Class I

  Feb. 3, 2025

• Advamed pushes for medical device exemption from Trump tariffs

  Feb. 3, 2025

• 4 robotic surgery trends to watch in 2025

  Jan. 29, 2025

• Doctors expect Boston Scientific to lead PFA race, survey finds

  Jan. 27, 2025

• Intuitive execs cast wary eye on potential Trump tariffs

  Jan. 24, 2025

• Masimo picks Katie Szyman as CEO

  Jan. 22, 2025

• Boston Scientific study meets goals for PFA in persistent AFib

  Jan. 21, 2025

• JPM25 recap: Robotics, PFA and OTC glucose sensors in the spotlight

  Jan. 17, 2025

• Intuitive CEO drills down on da Vinci 5 rollout, force feedback debate

  Jan. 16, 2025

• CMR Surgical makes interim CEO permanent

  Jan. 15, 2025

• CEO Geoff Martha tells JPM crowd Medtronic is ‘stacking growth drivers’

  Jan. 14, 2025

• Illumina, Nvidia team to use AI in foundation models

  Jan. 13, 2025

• J&J pauses Varipulse PFA cases in US

  Jan. 8, 2025

• Boston Scientific to buy remaining Bolt Medical stake for up to $664M

  Jan. 8, 2025

• Outset Medical to pay down debt after raising nearly $300M

  Jan. 7, 2025

• Olympus begins CEO search after Kaufmann resignation

  Jan. 3, 2025

• FDA closes 2024 with string of early alerts on device safety risks

  Jan. 3, 2025

• Heart valve developer Anteris launches IPO

  Dec. 20, 2024

• Merit Medical president to resign after unspecified conduct allegations

  Dec. 18, 2024

• PFA to surpass radiofrequency ablation in 2025: Citi survey

  Dec. 16, 2024

• Endoquest robotic system gets FDA OK to launch clinical trial

  Dec. 13, 2024

• Capstan Medical raises $110M for heart valve with robotic system

  Dec. 12, 2024

• Masimo lays off 75 employees in California

  Dec. 11, 2024

• Vicarious Surgical CFO William Kelly stepping down in January

  Dec. 10, 2024

• Smith & Nephew laying off about 150 employees in Tennessee

  Dec. 6, 2024

• Edwards expects new TAVR approval in mid-2025 to boost sales

  Dec. 5, 2024

• Haemonetics to offload whole-blood business for up to $67M

  Dec. 4, 2024

• How CMR Surgical is taking on robotics’ ‘800-pound gorilla’

  Dec. 3, 2024

• Medtronic nets FDA nod for smart insulin pen app

  Nov. 22, 2024

• Philips revises ventilator directions after airflow issue tied to 4 injuries

  Nov. 21, 2024

• Advamed CEO welcomes Dr. Oz as Trump’s pick to lead CMS

  Nov. 20, 2024

• Labcorp hires Julia Wang as CFO

  Nov. 20, 2024

• Boston Scientific’s Watchman could be new option for patients post ablation: study

  Nov. 18, 2024

• The PFA race is heating up. Here’s where the market stands after J&J’s approval.

  Nov. 18, 2024

• Haemonetics to close California facility, lay off 75 people

  Nov. 14, 2024

• J&J’s Ottava surgical robot to begin clinical trial after FDA nod

  Nov. 12, 2024

• Boston Scientific resumes PFA trial in new patient group after pausing enrollment

  Nov. 12, 2024

• Baxter to restart second IV fluid production line at hurricane-damaged site

  Nov. 11, 2024

• J&J wins FDA approval for Varipulse PFA system

  Nov. 7, 2024

• Masimo, amid leadership transition, targets cost reductions

  Nov. 6, 2024

• Medtronic, Recor win CMS transitional payment coverage for renal denervation devices

  Nov. 5, 2024

• FDA clears iRhythm’s second 510(k) in response to warning letter

  Nov. 1, 2024

• Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study

  Oct. 31, 2024

• Edwards data show benefit of early TAVR over ‘watchful waiting’

  Oct. 29, 2024

• FDA advises clinicians to stop using Hologic radiographic markers

  Oct. 28, 2024

• Edwards’ TAVR sales faced ongoing hospital constraints in Q3

  Oct. 25, 2024

• iRhythm’s Zio AT design changes win FDA clearance

  Oct. 23, 2024

• Boston Scientific boosts PFA expectations, citing rapid Farapulse adoption

  Oct. 23, 2024

• 5 steps to navigate the FDA’s new lab developed test rule

  Oct. 21, 2024

• Boston Scientific wins FDA approval for Farapulse cardiac mapping

  Oct. 21, 2024

• Intuitive readies da Vinci 5 for broader launch after placing 110 robots in Q3

  Oct. 18, 2024

• CMR Surgical gets FDA de novo nod for Versius robot

  Oct. 17, 2024

• Medtronic to evaluate Affera in ventricular tachycardia

  Oct. 15, 2024

• CMR Surgical CEO Bose steps down

  Oct. 10, 2024

• CMS begins national coverage review for tricuspid repair

  Oct. 8, 2024

• Medtronic recalls Minimed insulin pumps for reduced battery life

  Oct. 7, 2024

• BD agrees to settle most of its hernia mesh litigation

  Oct. 3, 2024

• Integer sells non-medical business for $50M

  Oct. 2, 2024

• GE Healthcare gets FDA nod for new PET imaging agent

  Oct. 1, 2024

• What’s next at Masimo after CEO Kiani’s exit?

  Sept. 30, 2024

• Congress again delays steep cuts in Medicare lab payments

  Sept. 26, 2024

• Masimo CEO, founder Kiani resigns

  Sept. 25, 2024

• FDA names new head of medical device evaluation and quality

  Sept. 24, 2024

• Masimo investor claims proxy war win as CEO Kiani fails to retain board seat

  Sept. 20, 2024

• Masimo proxy fight nears end as shareholder vote looms

  Sept. 19, 2024

• Exact Sciences says data support its colon cancer blood test

  Sept. 16, 2024

• Inflammatix raises $57M to advance test for infection, sepsis

  Sept. 13, 2024

• SS Innovations expects US OK for surgical robot in 2025

  Sept. 12, 2024

• J&J leads $50M financing for imaging company Spectrawave

  Sept. 11, 2024

• Smiths Medical links 1 death, 35 injuries to defective airway tubes

  Sept. 10, 2024

• Diagnostic errors are common. Here are 4 ways to prevent them.

  Sept. 6, 2024

• Edwards cuts more than 500 employees after critical care sale

  Sept. 5, 2024

• Illumina avoids fine for Grail purchase in European court victory

  Sept. 3, 2024

• Pathology group sues to block FDA lab test rule

  Aug. 30, 2024

• Insulet’s Trang Ly on overcoming ‘clinical inertia’ in diabetes care

  Aug. 27, 2024

• Stryker to add back pain treatment with Vertos Medical buy

  Aug. 23, 2024

• FDA defends Shuren’s tenure after report raises ethics concerns

  Aug. 22, 2024

• Masimo’s consumer audio brands attract more suitors

  Aug. 21, 2024

• J&J to buy heart failure implant maker V-Wave for up to $1.7B

  Aug. 20, 2024

• Edwards continues M&A spree with Genesis’ TAVR tech

  Aug. 19, 2024

• Histosonics raises $102M for noninvasive treatment to destroy tumors

  Aug. 19, 2024

• Stereotaxis earns CE mark for new surgical robot

  Aug. 15, 2024

• Grail to shed 350 workers in restructuring

  Aug. 14, 2024

• Baxter agrees to sell kidney care unit to Carlyle for $3.8B

  Aug. 13, 2024

• Experts fear patient harm from FDA’s lab developed test rule

  Aug. 5, 2024

• GE Healthcare faces pressure in China as hospitals delay orders

  Aug. 1, 2024

• Guardant wins FDA approval for colon cancer blood test

  July 29, 2024

• Edwards spends $1.2B on 2 heart device firms, extending deal streak

  July 25, 2024

• CDRH Director Shuren to step down after 15 years

  July 24, 2024

• ICU Medical to close Minnesota facility, cut 83 jobs

  July 23, 2024

• ‘Our next frontier is prediction’: Medtronic on AI and heart disease

  July 22, 2024

• Intuitive’s da Vinci 5 robot launch ‘well ahead’ of Wall Street expectations

  July 19, 2024

• Masimo sues activist investor Politan, postpones annual meeting

  July 16, 2024

• Edwards to acquire Innovalve, stake in Affluent Medical

  July 15, 2024

• FDA’s lab developed test rule could be first check on agency’s power post-Chevron

  July 11, 2024

• Masimo employees rally around CEO Kiani as proxy fight looms

  July 3, 2024

• Masimo COO says he’ll resign if CEO Kiani is forced out

  July 1, 2024

• Boston Scientific buys Silk Road Medical for $1.26B

  June 18, 2024

• PFA devices are changing AFib treatment. The next wave could grow the market further.

  June 17, 2024

• Agilent to cut 3% of employees as sluggish lab equipment market persists

  June 14, 2024

• Masimo embroiled in dual DOJ, SEC probes

  June 13, 2024

• Kardium raises $104M to develop pulsed field ablation system

  June 12, 2024

• Abbott issues recall for Heartmate system monitor

  June 11, 2024

• Moon Surgical secures FDA nod for commercial soft tissue robot

  June 5, 2024

• Illumina board approves Grail spinoff

  June 4, 2024

• Medtech venture capital investing rebounded in Q1

  June 3, 2024

• Steris to lay off employees in restructuring

  May 31, 2024

• Lab industry sues to stop FDA’s new LDT rule

  May 30, 2024

• Medtronic elevates Linnea Burman to president of neurovascular unit

  May 29, 2024

• FDA panel backs Guardant’s blood test for colon cancer

  May 24, 2024

• Guardant colon cancer test struggles to detect non-cancerous tumors, FDA says

  May 22, 2024

• Pulsed field ablation poised for fast adoption, analysts say

  May 20, 2024

• Boston Scientific recalls more than 1M angiographic catheters

  May 15, 2024

• Abbott recalls Heartmate pump after 70 injuries, 2 deaths reported

  May 15, 2024

• Pacific Biosciences to lay off 195 employees as part of cost cuts

  May 14, 2024

• Masimo offers Politan a concession to avoid second proxy fight

  May 10, 2024

• Abbott’s Jennifer Jones-McMeans on treating PAD below the knee

  May 9, 2024

• CMR Surgical names new CFO

  May 7, 2024

• Masimo’s at-home baby monitor cleared for use without prescription

  May 7, 2024

• Lab test overhaul: FDA to regulate LDTs as medical devices

  May 3, 2024

• Medline to buy Ecolab’s surgical products for nearly $1B

  May 1, 2024

• FDA defends LDT final rule, while critics fear it upends lab industry

  April 30, 2024

• FDA finalizes lab developed test rule despite industry opposition

  April 29, 2024

• Edwards gets Q1 boost as Pascal valve repair sales ramp up

  April 26, 2024

• Labcorp to acquire Invitae’s assets for $239M

  April 25, 2024

• Medtech’s top executive moves in 2024

  April 25, 2024

• Freenome to cut more than 100 employees in restructuring

  April 25, 2024

• EU launches probe of China’s medical device market

  April 24, 2024

• Cancer test maker Dermtech to cut 100 jobs, explore strategic options

  April 19, 2024

• Intuitive’s rollout of new da Vinci 5 robot steals Q1 spotlight

  April 19, 2024

• Bruker to acquire Nanostring for $393M

  April 18, 2024

• Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

  April 15, 2024

• Edwards pushes back on Medtronic’s head-to-head TAVR trial

  April 15, 2024

• Roche scores FDA breakthrough status for Alzheimer’s blood test

  April 12, 2024

• Abbott’s Nadim Geloo on Triclip’s US launch, Edwards competition

  April 12, 2024

• Robotic knee surgery study revives debate over procedure’s benefits

  April 9, 2024

• FTC asks Boston Scientific for more info on $3.7B Axonics deal

  April 4, 2024

• QuidelOrtho pulls FDA submission of 4-virus test

  April 3, 2024

• Abbott nets FDA approval for Triclip

  April 2, 2024

• Masimo faces another proxy challenge from Politan Capital

  April 1, 2024

• Hologic to lay off 190 workers as it closes European facilities

  March 28, 2024

• Masimo to split off consumer business

  March 25, 2024

• As FDA’s LDT rule looms, experts warn patients may lose access to critical tests

  March 22, 2024

• Intuitive aims to keep challengers at bay with new surgical robot

  March 20, 2024

• Intuitive details launch plan for new da Vinci 5 robot

  March 18, 2024

• Intuitive lands FDA clearance for new da Vinci robot

  March 15, 2024

• QuidelOrtho to lay off employees after firing CEO

  March 14, 2024

• Abbott recalls Heartmate LVAD communication system

  March 12, 2024

• Former Stimwave CEO found guilty of selling fake implantable device component

  March 8, 2024

• Vicarious presses forward with soft tissue robot despite struggles

  March 6, 2024

• Haemonetics to buy Attune Medical for $160M

  March 5, 2024

• Boston Scientific gains FDA nod for drug-coated coronary balloon

  March 1, 2024

• Abbott leader on the ‘hype’ and ‘reality’ of pulsed field ablation

  March 1, 2024

• J&J’s pulsed field ablation system secures European approval

  Feb. 29, 2024

• J&J begins enrolling patients in Laminar LAA pivotal trial

  Feb. 28, 2024

• Integra Lifesciences to cut about 60 jobs as it closes Indiana site

  Feb. 27, 2024

• Agiliti to go private in $2.5B PE deal

  Feb. 26, 2024

• New GT Medical CEO Per Langoe on driving adoption of brain tumor therapy

  Feb. 23, 2024

• Agilent’s McDonnell to succeed retiring CEO McMullen

  Feb. 22, 2024

• UK medical device reviewers form new association

  Feb. 20, 2024

• Illumina cut 12% of global staff over past year: CEO

  Feb. 9, 2024

• Illumina to lay off 111 people at San Diego headquarters

  Feb. 8, 2024

• How Edwards’ Evoque valve won an early nod from the FDA

  Feb. 7, 2024

• Invitae hires advisers, considers bankruptcy: WSJ

  Feb. 7, 2024

• Nanostring files for bankruptcy protection, explores possible sale

  Feb. 5, 2024

• FDA to reclassify most high-risk IVDs, easing path to clearance

  Feb. 5, 2024

• Boston Scientific nets Farapulse approval, pushes back US TAVR launch

  Jan. 31, 2024

• 4 heart device trends shaping the medtech sector in 2024

  Jan. 30, 2024

• Vicarious Surgical hires former Olympus leader as president

  Jan. 30, 2024

• How Masimo forced Apple to redesign its smartwatches

  Jan. 26, 2024

• Robot reveal: Intuitive submits 510(k) for next-generation system

  Jan. 24, 2024

• Apple to sell watches without pulse oximetry after ban of original design takes effect

  Jan. 18, 2024

• Apple, locked in patent fight with Masimo, redesigns smartwatch

  Jan. 16, 2024

• Intuitive CEO: Strong robot placements offset bariatric surgery slowdown

  Jan. 11, 2024

• Medtronic focused on delivering durable revenue and profit growth

  Jan. 9, 2024

• Boston Scientific to buy Axonics for $3.7B to gain incontinence treatment

  Jan. 8, 2024

• Thermo Fisher to lay off 74 California workers in restructuring

  Jan. 5, 2024

• Apple Watch sales resume after latest twist in Masimo patent case

  Jan. 3, 2024

• Agilent to lay off about 400 workers amid site closures

  Dec. 22, 2023

• Roundup: Illumina’s long goodbye to cancer test maker Grail

  Dec. 21, 2023

• Apple to pause US sales of smartwatches with pulse oximetry

  Dec. 20, 2023

• Grail CEO predicts ‘transformative’ 2024 amid Illumina split

  Dec. 19, 2023

• Illumina to part with Grail, ending battle with regulators

  Dec. 18, 2023

• Medtronic snags first pulsed field ablation approval in US

  Dec. 14, 2023

• In wake of Philips recall, senators urge review of FDA medical device oversight

  Dec. 14, 2023

• Illumina prepares to divest Grail with Form 10 filing

  Dec. 13, 2023

• Why heart device makers are investing in left atrial appendage closure

  Dec. 12, 2023

• Henry Schein says 29K people affected in September cyber incident

  Dec. 8, 2023

• Intuitive’s venture capital arm launches second investment fund

  Dec. 5, 2023

• Moon Surgical CEO Anne Osdoit on readying a soft tissue robot for launch

  Dec. 1, 2023

• J&J heats up LAA closure competition with $400M Laminar buy

  Nov. 30, 2023

• 3 medtech spinoffs that reshaped the industry in 2023, and what to expect next

  Nov. 29, 2023

• Orthofix hires new CEO, 2 months after former leaders ousted

  Nov. 28, 2023

• Medtronic to chase Boston Scientific, Abbott in left atrial appendage closure market

  Nov. 28, 2023

• Labcorp to lay off 239 workers in New Jersey amid biotech slump

  Nov. 22, 2023

• Congress delays Medicare lab payment cuts for one year

  Nov. 16, 2023

• Stolen Medtronic laryngoscopes deemed Class 1 recall

  Nov. 15, 2023

• Biden initiative aims to accelerate women’s health research

  Nov. 14, 2023

• Wegovy study details revive debate over GLP-1 impact on devices

  Nov. 13, 2023

• Illumina explores options for Grail, hires advisers

  Nov. 10, 2023

• Masimo lowers outlook, citing constrained hospital budgets

  Nov. 8, 2023

• J&J targets 2024 for Ottava FDA filing

  Nov. 7, 2023

• Elective procedure interest still topping pre-COVID levels, survey finds

  Nov. 3, 2023

• Inari Medical to buy limb-saving device maker LimFlow for up to $415M

  Nov. 3, 2023

• Baxter completes biopharma solutions sale, business unit revamp

  Nov. 2, 2023

• Drilling down on obesity drugs: What medtech executives are saying

  Nov. 2, 2023

• FDA holds firm on 60-day comment period for lab-developed test rule

  Nov. 1, 2023

• 4 medtech companies to watch this week in earnings

  Oct. 30, 2023

• Masimo prevails against Apple in USITC patent investigation

  Oct. 27, 2023

• Baxter’s Heather Knight talks combating sepsis — and how AI can help

  Oct. 27, 2023

• Thermo Fisher cuts 2023 forecast, citing volatile economic conditions

  Oct. 25, 2023

• Danaher Q3 revenue declines as demand challenges continue

  Oct. 24, 2023

• Medtronic gains FDA approval for extravascular defibrillator

  Oct. 23, 2023

• Intuitive’s Q3 sales miss estimates as robot leasing, China demand weigh

  Oct. 20, 2023

• Interventional Systems gets second 510(k) clearance for miniature robot

  Oct. 19, 2023

• Abbott raises outlook amid strong Q3, sees momentum into 2024

  Oct. 18, 2023

• Thermo Fisher buys Olink Holding for $3.1B, pushing further into proteomics

  Oct. 17, 2023

• Illumina details EC timeline, funding requirements for Grail divestment

  Oct. 13, 2023

• European Commission orders Illumina to divest Grail

  Oct. 12, 2023

• Top medtech conferences remaining in 2024

  Oct. 12, 2023

• J&J’s Abiomed hit with FDA warning letter over Impella heart pump

  Oct. 12, 2023

• AdvaMed elevates digital health center to division, names board

  Oct. 10, 2023

• Insulet wins preliminary injunction against EOFlow in patent suit

  Oct. 9, 2023

• Medtronic hires neuromodulation president from Smith+Nephew

  Oct. 5, 2023

• Akura Medical secures $35M to pursue FDA clearance for thrombectomy device

  Oct. 4, 2023

• Invitae test for hereditary cancers gains FDA de novo nod

  Oct. 3, 2023

• Accuray’s Suzanne Winter to lead AdvaMed radiotherapy sector

  Oct. 2, 2023

• Galen robot gets FDA de novo clearance for ENT surgeries

  Sept. 28, 2023

• Edwards Lifesciences says it was target of surprise EU antitrust inspection

  Sept. 26, 2023

• Developer of miniaturized surgical robot extends funding round

  Sept. 25, 2023

• CMR Surgical secures $165M for its robot expansion

  Sept. 21, 2023

• EU antitrust officials make surprise inspections at cardiovascular device company

  Sept. 20, 2023

• MedTech Europe says MDR, IVDR framework needs ‘structural reform’

  Sept. 18, 2023

• Hospital, lab equipment makers brace for China demand slowdown

  Sept. 15, 2023

• Orthofix fires CEO, CFO after investigation finds misconduct

  Sept. 13, 2023

• Centinel Spine to sell fusion business, focus on disc replacement

  Sept. 11, 2023

• Intuitive’s Tony Jarc on how AI is improving robotic surgery

  Sept. 8, 2023

• Zimmer Biomet promotes 3 executives

  Sept. 7, 2023

• Synchron brain-computer interface implanted in first 6 US patients

  Sept. 6, 2023

• Illumina names Agilent’s Jacob Thaysen as its next CEO

  Sept. 5, 2023

• Noah Medical lung biopsy robot exceeds expectations in first-in-human trial

  Sept. 1, 2023

• Abbott study shows benefits of OCT imaging in stent placement

  Aug. 31, 2023

• Hopes dim for Medtronic hypertension treatment after FDA panel rebuff

  Aug. 29, 2023

• Medtronic renal denervation device hits setback at FDA panel

  Aug. 24, 2023

• Recor wins FDA panel’s backing for high blood pressure device

  Aug. 23, 2023

• Axonics appoints Kari Keese to CFO post as Dan Dearen retires

  Aug. 22, 2023

• Agilent to wind down Resolution Bioscience liquid biopsy unit

  Aug. 21, 2023

• Bruker to buy PhenomeX and its cell research tools for $108M

  Aug. 18, 2023

• Labcorp scoops up Tufts Medicine outreach lab, continuing buying spree

  Aug. 15, 2023

• Illumina faces SEC probe over Grail acquisition

  Aug. 14, 2023

• Illumina shakes up executive team, lowers 2023 outlook

  Aug. 10, 2023

• Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations

  Aug. 9, 2023

• Guardant, Illumina agree to end litigation, extend commercial partnership

  Aug. 8, 2023

• Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery

  Aug. 4, 2023

• Augmedics picks up Surgalign’s digital health assets for $900K

  Aug. 1, 2023

• Vicarious expects to perform first human procedure with robot next year

  July 31, 2023

• Thermo Fisher eyes $450M in cost cuts due to slowing demand

  July 28, 2023

• Boston Scientific raises full-year forecast again, fueled by strong Q2

  July 27, 2023

• Regulatory specialist pleads guilty to forging FDA clearance letters

  July 26, 2023

• Inspire Medical hires Medtronic veteran as new strategy chief

  July 24, 2023

• Philips reports 9% sales jump, in rebound from sleep device recall

  July 24, 2023

• BD gains FDA clearance to relaunch Alaris infusion pump after recalls

  July 24, 2023

• Bariatric surgery slowdown nips Intuitive Surgical’s Q2 procedure growth

  July 21, 2023

• Abbott Q2 net profit falls as weaker COVID test sales drag on revenue

  July 20, 2023

• Medtronic recalls nearly 350,000 defibrillators for risk of reduced shock

  July 18, 2023

• Masimo plans cost cuts as Q2 revenue falls short of expectations

  July 18, 2023

• Court allows Axonics neurostim patent case to proceed against Medtronic

  July 14, 2023

• Illumina hit by EU with maximum €432M fine for Grail acquisition

  July 12, 2023

• Masimo’s board turnover could bring Sound United spinoff, analysts say

  July 11, 2023

• Illumina’s ‘inevitable’ split from Grail likely by mid-2024, analysts say

  July 6, 2023

• Medtronic identifies cybersecurity vulnerability in cardiac data system

  July 5, 2023

• Former J&J sales rep indicted on charges of defrauding Boston hospital

  June 28, 2023

• Masimo shareholders elect activist investor’s two board candidates

  June 27, 2023

• CMS proposes pathway to earlier breakthrough device coverage

  June 23, 2023

• Showdown at Masimo: Proxy battle targets CEO Kiani’s leadership, board

  June 23, 2023

• Medtronic will distribute Allurion’s swallowable weight-loss balloon

  June 22, 2023

• Surmodics secures FDA nod for PAD balloon, earning payment from Abbott

  June 20, 2023

• Glass Lewis, joining ISS, supports activist’s candidates for Masimo board

  June 16, 2023

• Robotic surgery market shows no signs of slowing, favoring Intuitive’s da Vinci: J.P. Morgan

  June 15, 2023

• Americans’ use of healthcare wearables expanding rapidly, survey says

  June 14, 2023

• Masimo proxy fight heats up as ISS backs activist’s board nominees

  June 14, 2023

• As Illumina’s deSouza departs, will Grail go next?

  June 12, 2023

• Merit Medical buys two dialysis catheter lines for $132.5M combined

  June 9, 2023

• Illumina appeals FTC’s order to divest Grail with plea for cancer screening test

  June 6, 2023

• Medtronic names former Amazon robotics VP as technology chief

  June 5, 2023

• Grail blames vendor glitch for patient notifications of incorrect cancer diagnosis

  June 5, 2023

• Deaths reported with Philips ventilators, sleep apnea machines still climbing

  June 2, 2023

• Illumina adds 2 medtech execs to its board, weakening Icahn’s influence

  June 2, 2023

• Medtronic’s Brewer jumps to Baxter to lead patient support systems

  June 1, 2023

• Friday Q&A: Stanford Biodesign’s Makower on expediting Medicare coverage for breakthrough devices

  May 26, 2023

• ‘Genuine bull market’ underway in medtech stocks, says CNBC’s Cramer

  May 23, 2023

• Vicarious, preparing to take on Intuitive in robotic surgery, names new COO

  May 22, 2023

• A Boston Scientific purchase of Shockwave could be transformative — but at what price?

  May 19, 2023

• Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight

  May 17, 2023

• Intuitive Surgical promotes Dave Rosa to president, Guthart remains CEO

  May 16, 2023

• Icahn bolstered by another proxy advisor in battle with Illumina

  May 15, 2023

• Philips agrees to pay SEC more than $62M to settle China corruption charges

  May 12, 2023

• Thermo Fisher, Pfizer partner to boost NGS cancer testing outside U.S.

  May 10, 2023

• Illumina defends its board, calls Icahn campaign ‘character assassination’

  May 8, 2023

• Friday Q&A: Boston Scientific’s De Rosa on the rise of an AFib ‘game changer’

  May 5, 2023

• Boston Scientific gets DOJ subpoena for documents related to heart monitoring

  May 5, 2023

• Icahn says his Illumina board candidates will ‘ask the tough questions’

  May 5, 2023

• BD raises full-year forecasts again, expects Alaris infusion pump approval

  May 4, 2023

• Thermo Fisher plans another round of layoffs in California, as profits fall

  May 3, 2023

• Masimo suit against Apple over smartwatch trade secrets ends in mistrial

  May 2, 2023

• Illumina gets cybersecurity warning from FDA over sequencing software

  April 27, 2023

• Quest Diagnostics to pay $450M to buy liquid biopsy cancer test developer as Q1 revenue drops

  April 27, 2023

• Boston Scientific Q1 sales top expectations on ‘healthy’ market demand

  April 26, 2023

• Labcorp posts Q1 net decline, says Fortrea spinoff on track for mid-year

  April 25, 2023

• Philips says revenue rises 6%, sees €575M in recall-related legal costs

  April 24, 2023

• Alphatec buys robotic spine navigation system for $55M

  April 21, 2023

• Friday Q&A: Abbott’s Vish Charan on muscling into the leadless pacemaker market

  April 21, 2023

• Abbott boosts organic sales outlook as device demand accelerates

  April 19, 2023

• iCAD, in midst of restructuring, names three new top executives

  April 17, 2023

• Friday Q&A: Medtronic’s Ajizian talks connected care ahead of unit spinoff

  April 15, 2023

• Genomics companies Ultima, Genome Insight partner to offer low-cost sequencing

  April 14, 2023

• Medtronic, 6 months after proposing patient monitoring spinoff, remains mum on separation plan

  April 14, 2023

• Illumina-Icahn proxy battle heats up as Grail divestment orders loom

  April 12, 2023

• Icahn pushes for spinoff of Illumina’s Grail liquid biopsy unit

  April 11, 2023

• Illumina backs its board in proxy fight with Icahn

  April 10, 2023

• EPA proposes stricter ethylene oxide pollutant rules for chemical makers

  April 7, 2023

• Bioventus CEO departs after CartiHeal acquisition unravels

  April 6, 2023

• Diagnostics execs charged with concealing lead test flaw

  April 5, 2023

• Why won’t Illumina sell Grail?

  April 4, 2023

• Illumina ordered to divest Grail by FTC on anticompetition concerns

  April 3, 2023

• Bain acquires Olympus life sciences unit for $3.1B

  April 3, 2023

• Illumina urges shareholders to reject Icahn board nominees

  March 31, 2023

• Surmodics receives FDA feedback weeks after layoffs

  March 30, 2023

• Breast cancer AI company iCAD lays off workers, names new CEO

  March 29, 2023

• Qiagen’s Thierry Bernard named chair of the AdvaMedDx board

  March 28, 2023

• Implantable heart failure sensors cut death risk in study: Abbott

  March 27, 2023

• Bill would require Medicare to cover breakthrough devices for four years

  March 27, 2023

• Icahn says Illumina directors got personal insurance after Grail deal

  March 24, 2023

• Friday Q&A: Movano takes on the women’s wearables market with a smart ring

  March 24, 2023

• Roche, Lilly team on test for early detection of Alzheimer’s

  March 22, 2023

• Spine robot maker Accelus gains another FDA clearance

  March 21, 2023

• Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail

  March 20, 2023

• Robot maker CMR Surgical appoints new CEO as it looks to ramp system sales

  March 17, 2023

• Friday Q&A: A startup founder tackles the riddle of why we cough

  March 17, 2023

• Medtronic wins CE mark for ablation device, invests in heart failure monitoring company

  March 16, 2023

• Illumina shares jump 17% after Icahn launches proxy fight

  March 13, 2023

• Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation

  March 13, 2023

• Medtech groups lose challenge to digital piracy rule in device repair case

  March 13, 2023

• Friday Q&A: A regulatory attorney breaks down the EU MDR transition

  March 10, 2023

• Abbott gets FDA nod on lab blood test for concussion

  March 8, 2023

• AdvaMed calls Europe’s MDR extension a ‘strong step forward,’ but warns challenges remain

  March 7, 2023

• Medtech industry relieved as Europe’s MDR extension nears final approval

  March 6, 2023

• AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access

  March 1, 2023

• iRhythm beats Q4 expectations, shares rise on Zio XT account openings

  Feb. 24, 2023

• Friday Q&A: GE HealthCare’s Yoder on using AI to drive precision care

  Feb. 23, 2023

• Medtronic relaunches pulmonary valve that was subject of recall

  Feb. 23, 2023

• Medtronic boosts full-year outlook as supply challenges subside

  Feb. 21, 2023

• Device makers gain more time to adapt to Europe’s MDR after EU vote

  Feb. 17, 2023

• Baxter spinoffs move forward as three execs made group presidents in new business structure

  Feb. 17, 2023

• Robot startup Vicarious is latest medtech company to cut jobs

  Feb. 15, 2023

• Baxter, Abbott, Thermo Fisher among medtech firms cutting jobs on supply issues, slide in testing

  Feb. 13, 2023

• Thermo Fisher cuts additional 230 jobs in California

  Feb. 10, 2023

• Abbott to pay $890M to acquire CSI, gaining atherectomy device

  Feb. 9, 2023

• Abbott balloon device partner Surmodics cuts jobs after FDA approval delay

  Feb. 9, 2023

• UK health system, under strain, lays out medtech strategy

  Feb. 7, 2023

• Invacare files for Chapter 11 bankruptcy protection amid supply chain woes

  Feb. 3, 2023

• BD raises full-year forecast, sees Q1 strength in pharmacy automation, pre-fillables

  Feb. 2, 2023

• Boston Scientific gets Q4 boost from heart, urology sales

  Feb. 1, 2023

• CFO survey hints at funding shift from robots to wearables

  Feb. 1, 2023

• Edwards posts Q4 profit, reaffirms 2023 outlook as patients return

  Feb. 1, 2023

• Medtronic recalls 22,000 hemodialysis catheters for potential hub defect

  Jan. 30, 2023

• ResMed quarterly revenue beats estimates as supply chain woes ease

  Jan. 27, 2023

• Cybersecurity ‘more critical than ever’ in era of connected care: BD

  Jan. 25, 2023

• 18M projected to lose Medicaid coverage at end of COVID-19 emergency

  Dec. 6, 2022

• MedTech Innovators: Tissium co-founder Maria Pereira on taking tech from bench to bedside

  Nov. 30, 2022

• Q3 Earnings Wrap: Bumpy time for medtech with inflation, FX, supply woes

  Nov. 21, 2022

• HHS cybersecurity center warns of new ransomware threat

  Nov. 14, 2022

• Friday Q&A: FemTech Focus’s Barreto discusses women’s health innovations, funding challenges

  Nov. 4, 2022

• Robots cushion omicron's blow to Q4 orthopaedic device sales

  Feb. 8, 2022

• CDRH pledges greater focus on women's health data

  Jan. 19, 2022

• Medtech's biggest deals in 2021 and what to expect next

  Jan. 4, 2022

• Hospitals clamp down on elective surgeries as COVID-19 surges

  Dec. 22, 2021

• Getinge intra-aortic balloon pump recall tied to 1 death, 71 complaints

  Dec. 17, 2021

• 3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures

  Dec. 15, 2021

• Flurry of doctor group buyouts helps fuel 'extraordinary' surge in health M&A

  Dec. 14, 2021

• Neurostimulator to treat stroke fails to gain FDA advisory panel support

  Dec. 13, 2021

• Insulet's Omnipod 5 insulin pump cleared by FDA after months of delays, sending shares up 9%

  Dec. 6, 2021

• CMS proposes smokers begin lung cancer screening at age 50 instead of 55

  Nov. 22, 2021

• FDA to regulate lab developed tests in policy reversal

  Nov. 16, 2021

• FDA questions safety of Philips replacement foam for recalled devices

  Nov. 15, 2021

• GE unveils plan to spin off healthcare business

  Nov. 10, 2021

• Philips grows cardiac monitoring business with Cardiologs pickup

  Nov. 9, 2021

• Zimmer, J&J chase Stryker's lead in ortho robotics

  Oct. 25, 2021

• Intuitive says delta variant slows Q3 da Vinci procedure growth

  Oct. 20, 2021

• Abbott, Dexcom could benefit from CGM use jump among Type 2 diabetes patients: report

  Oct. 13, 2021

• Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks

  Oct. 5, 2021

• Medtronic embolization device hit with another Class I recall, 2 deaths cited

  Sept. 21, 2021

• TransMedics wins FDA nod for donor heart preservation system

  Sept. 7, 2021

• Zimmer 'smart knee' gets FDA nod as ortho rivalry with Stryker heats up

  Aug. 31, 2021

• COVID-19 seems to skew Abbott heart failure monitor study results

  Aug. 30, 2021

• Diabetes screening advised to start at age 35 for overweight, obese people

  Aug. 25, 2021

• Robotic mastectomy's safety and effectiveness unproven, FDA warns

  Aug. 23, 2021

• Zimmer beats Q2 expectations, pandemic still a drag on large joint procedures

  Aug. 3, 2021

• As Stryker boosted by electives comeback, CEO downplays delta variant risk to procedures

  July 28, 2021

• Intuitive's Q2 robot placements accelerate amid procedure recovery

  July 21, 2021

• Medtech funding surges with early-stage deals

  July 20, 2021

• Medtronic's recall of unsterilized angiography guidewires labeled Class I event by FDA

  July 6, 2021

• FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset

  June 28, 2021

• UnitedHealthcare skimping on COVID-19 test pay: California doctors group

  June 21, 2021

• Hip, knee bundled pay program results similar as voluntary or mandatory: JAMA study

  June 16, 2021

• HHS commits $4.8B to COVID-19 testing for the uninsured

  May 26, 2021

• Apple Watch faces ITC probe sparked by AliveCor complaint

  May 25, 2021

• FDA clears 2 endoscopes that avoid reprocessing

  May 25, 2021

• Labs urge HHS to back new regulatory regime for diagnostic tests

  May 24, 2021

• Boston Scientific's Watchman shows low stroke rate in large registry at ACC

  May 17, 2021

• Paclitaxel, uncoated stents for PAD show similar mortality in real world study

  May 17, 2021

• OIG calls on EPA to review ethylene oxide cancer risks, possibly delaying new regulations until 2022

  May 11, 2021

• Robotic surgery outlook boosted by hospital spending pickup in Q1

  May 10, 2021

• Orthopaedic companies project 'return to normalcy' as electives recover in Q1

  May 3, 2021

• Stryker's Wright costs spur Q1 miss, but robotics orders pick up

  April 28, 2021

• FDA greenlights device to retrain muscles in stroke patients

  April 26, 2021

• Science groups urge caution against using certain COVID-19 test data

  April 23, 2021

• Moody's predicts brisk pace of medtech M&A amid earnings optimism

  April 22, 2021

• Intuitive sees Q1 robot rebound in turnabout from start of year

  April 21, 2021

• AdvaMed pushes CMS to implement MCIT final rule without further delay

  April 19, 2021

• FDA drops 8 medical software functions from oversight

  April 19, 2021

• Suit alleging Medtronic misled FDA over spine fusion can proceed, appeals court says

  April 7, 2021

• Fewer heart tests ordered for telehealth patients in pandemic

  April 6, 2021

• FDA warns of patient deaths tied to reusable urological endoscopes

  April 5, 2021

• A year into the pandemic, advanced cancer diagnoses are rising

  March 31, 2021

• FDA panel to probe Endologix, broader stent graft safety in November

  March 30, 2021

• Medtronic's Harmony pulmonary valve wins FDA approval

  March 29, 2021

• Boston Scientific to pay $188.6M to settle mesh claims in 47 states

  March 24, 2021

• CMS puts the brakes on breakthrough device coverage rule

  March 16, 2021

• FDA flags risk of device fracture in Colfax's STAR ankle replacements

  March 16, 2021

• Hillrom steps back from $375M BardyDx deal on reimbursement setback

  March 1, 2021

• Hillrom patient lift tied to 2 deaths, designated as Class I recall

  Feb. 23, 2021

• COVID-19 EUAs drive FDA to record 2020 novel device OKs

  Feb. 17, 2021

• BD drug-coated balloon faces uphill battle in FDA panel review

  Feb. 16, 2021

• Alinity, da Vinci top hospital purchasing execs' wish lists: UBS

  Feb. 9, 2021

• DoD awards Ellume $231M to increase US production of at-home, OTC COVID-19 test

  Feb. 2, 2021

• From COVID-19 EUAs to 'insidious' remote care risks: ECRI's top 10 medtech hazards

  Feb. 1, 2021

• Surmodics drug-coated balloon on par with Medtronic's in study

  Jan. 26, 2021

• Hillrom makes cardiac monitoring play with $375M BardyDx buy

  Jan. 20, 2021

• FDA issues action plan for regulating AI in medical devices

  Jan. 13, 2021

• Healthcare CFOs see fresh wave of M&A in 2021: BDO poll

  Jan. 12, 2021

• Stryker buys sensor maker in bet on wearables in orthopaedics

  Jan. 5, 2021

• Hologic eyes future post COVID-19 with Somatex Medical tuck-in

  Jan. 5, 2021

• The top medtech deals of 2020 (and one that got away)

  Jan. 4, 2021

• FDA 2020 recall roundup: A rough year for infusion pumps

  Dec. 23, 2020

• Testing demand for Labcorp, Quest robust even as COVID-19 vaccine administration begins

  Dec. 18, 2020

• FDA lays out alternative 510(k) path criteria for 3 device types

  Dec. 15, 2020

• FDA grants EUA for first fully at-home COVID-19 test without a prescription

  Dec. 15, 2020

• BD calls for 'Zero Trust' to combat rising healthcare hacking amid pandemic

  Dec. 14, 2020

• Bayer updates Essure birth control device reports of deaths, injuries on social media

  Dec. 8, 2020

• Endologix AAA graft to go before FDA panel over potential life-threatening leak risk

  Dec. 7, 2020

• Breast cancer tech among FDA's latest breakthrough nods

  Nov. 24, 2020

• GenScript wins 1st FDA nod to test for antibodies that could neutralize COVID-19

  Nov. 9, 2020

• FDA greenlights digital therapeutic for Apple Watch to quell PTSD nightmares

  Nov. 9, 2020

• Docs paid by ICD makers more likely to favor manufacturer: JAMA study

  Nov. 4, 2020

• MedPAC pans CMS idea to lean on commercial payers for Medicare coverage decisions

  Nov. 3, 2020

• Neovasc angina device fails to win FDA panel backing, stock tumbles 43%

  Oct. 28, 2020

• Neovasc refractory angina treatment faces FDA panel review

  Oct. 27, 2020

• Future of COVID-19 products, device shortages, CDS top CDRH 2021 to-do list

  Oct. 19, 2020

• With rivals delayed, Intuitive Surgical extends use of robotic instruments

  Oct. 14, 2020

• Elective surgeries seen driving Q3 medtech comeback, but can it last?

  Oct. 13, 2020

• TCT 2020: Abbott devices, TAVR systems headline late breaker lineup

  Oct. 12, 2020

• Steris inks $850M deal for Key Surgical adds to medtech M&A wave

  Oct. 7, 2020

• Medical Alley, GI docs push to ease CMS device pass-through payments

  Oct. 6, 2020

• CMS officials elaborate on proposed breakthrough device coverage pathway

  Oct. 6, 2020

• FDA finalizes black box warning for breast implants

  Sept. 29, 2020

• CMS lowers barriers for labs seeking COVID-19 test certification

  Sept. 28, 2020

• FDA launches years-in-the-making digital health center

  Sept. 23, 2020

• FDA De Novo OKs outpace 2019 with Spineology device, two others

  Sept. 22, 2020

• CMS to push back radiation oncology model after industry blowback

  Sept. 21, 2020

• Medtronic, Stryker among CEOs weighing in on COVID-19 recovery

  Sept. 15, 2020

• FDA finalizes voluntary consensus standard guidance

  Sept. 15, 2020

• Abbott, Illumina, other medtechs shape guide conveying device risks to patients

  Sept. 14, 2020

• LabCorp, DiaSorin tests differentiate COVID-19, flu, RSV

  Sept. 9, 2020

• Ortho device reclassifications, MDUFA reauthorization among FDA's fall meeting lineup

  Sept. 8, 2020

• Florida cuts ties with Quest after delayed reporting of 75K COVID-19 test results

  Sept. 2, 2020

• Smartwatch EKGs could speed diagnosis of deadly heart syndrome, small study suggests

  Sept. 1, 2020

• CMS pitches coverage of breakthrough devices in tandem with FDA authorization

  Aug. 31, 2020

• FDA proposes adding patient voice in device evaluation

  Aug. 31, 2020

• Stryker stretches Wright Medical share offer into Q4

  Aug. 28, 2020

• Google Health, Philips among players pitching digital therapeutics standards

  Aug. 26, 2020

• FDA-industry group touts real-world evidence framework to speed test development

  Aug. 25, 2020

• FDA looks to downclass noninvasive bone growth stimulators, incumbents not on board

  Aug. 17, 2020

• Inari Medical revenue rises in 1st quarterly report since public debut

  Aug. 12, 2020

• Guardant companion diagnostic gets FDA nod as 1st liquid biopsy with NGS

  Aug. 10, 2020

• iRhythm stock leaps 33% after CMS pitches new reimbursement codes

  Aug. 5, 2020

• Medtronic, in catch-up to Axonics, wins nod for rechargeable bladder and bowel control device

  Aug. 4, 2020

• House panel asks IG to investigate Trump admin bungling of Philips ventilator deal

  Aug. 3, 2020

• Hologic blows away earnings expectations on COVID-19 testing surge

  July 30, 2020

• FDA finalizes guidance on multiple-function devices after industry feedback

  July 29, 2020

• Robot redux: Pandemic scrambles competitive timelines for Intuitive, J&J, Medtronic

  July 28, 2020

• Hologic wins HHS-DOD contract to boost COVID-19 test supplies production

  July 28, 2020

• Intuitive plans to lower instrument prices as it warns of long recovery

  July 22, 2020

• As pandemic rages on, hip and knee surgeons lay out elective procedure guidance

  July 20, 2020

• Smith & Nephew launches new hand-held robotic tool amid COVID-19 health sector pullback

  July 15, 2020

• ElectroCore noninvasive nerve stimulator gets EUA for COVID-19 patients with asthma

  July 14, 2020

• Shareholder challenges Thermo Fisher's $11.5B deal to buy Qiagen

  July 13, 2020

• Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate

  July 8, 2020

• Digital health funding defies expected pandemic-era slowdown

  July 7, 2020

• Study design for CVRx device can serve as heart failure model: JACC editorial

  July 2, 2020

• Sidekick, Pfizer team on digital therapeutic for chronic disease

  June 30, 2020

• 5-minute, quantitative COVID-19 antibody test snags BARDA backing

  June 24, 2020

• Medtronic Evolut TAVR system gets expanded label in Europe

  June 23, 2020

• BARDA backs study of Empatica's COVID-19 early warning platform

  June 22, 2020

• Thermo Fisher, MedRhythms gain breakthrough device designations

  June 17, 2020

• Myriad prostate cancer test wins coverage from Aetna

  June 16, 2020

• Medtronic inks up to $337M in diabetes funding, Blackstone Life Sciences' 1st medtech investment

  June 15, 2020

• Cepheid developing test to distinguish COVID-19 from flu

  June 10, 2020

• Edwards wins approval to introduce Sapien 3 valve in China

  June 9, 2020

• Boston Scientific secures CMS pass-through nod for single-use endoscopes

  June 8, 2020

• FDA Breakthrough Devices Program nears 300 designations

  May 27, 2020

• Inari Medical launches IPO, shares take off

  May 26, 2020

• AdvaMed, health systems set ground rules for return of sales reps

  May 20, 2020

• Edwards secures CE mark for Pascal tricuspid valve repair device

  May 19, 2020

• Philips lung ultrasound, Beckman sepsis diagnostic receive BARDA coronavirus backing

  May 19, 2020

• Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves

  May 18, 2020

• House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package

  May 13, 2020

• Wright Medical sales miss consensus as lower extremities business drags

  May 12, 2020

• AtriCure treatment for persistent AFib shows superiority in study

  May 11, 2020

• Guardant offers 'encouraging' colorectal cancer screening update, as analysts await further data

  May 6, 2020

• Oncology systems maker Varian ekes out sales gain amid procedure delays

  May 5, 2020

• Ventilator sharing among states critical to save COVID-19 patient lives: Health Affairs paper

  May 4, 2020

• Hologic to launch 2nd coronavirus test amid broader sales slide

  April 30, 2020

• FDA says 18 deaths linked to intragastric weight loss balloons

  April 28, 2020

• FDA encourages remote review of digital pathology slides amid COVID-19

  April 27, 2020

• Edwards sees 14% sales bump in Q1, but near-term TAVR prospects grim

  April 24, 2020

• FDA finalizes post-inspection feedback protocol for medical device makers

  April 22, 2020

• As COVID-19 antibody tests proliferate, analysts see market worth billions for Abbott, Roche and others

  April 21, 2020

• CMS, surgeons group offer paths forward to resume elective procedures

  April 20, 2020

• Device to wean COVID-19 patients off ventilators gains EUA

  April 15, 2020

• CMS removes ventilators from DME bidding program due to high coronavirus demand

  April 14, 2020

• J&J, Takeda cancel $400M surgical patch deal after antitrust scrutiny

  April 13, 2020

• FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 sterilizers

  April 13, 2020

• OraSure wins BARDA contract for in-home coronavirus self-test

  April 8, 2020

• Study questions TAVR access disparities under new CMS coverage policy

  April 7, 2020

• FDA allows for infusion pump modifications to prevent shortages

  April 6, 2020

• BD rolls out test to detect coronavirus antibodies

  April 1, 2020

• FDA flags Class I recall of Medtronic brain stent, citing fracture reports

  March 31, 2020

• Medtronic's renal denervation system shows it can lower blood pressure

  March 30, 2020

• Medtech industry asks for FEMA's help allocating ventilators to frontlines

  March 25, 2020

• Senseonics halts new CGM sales, pulls 2020 guidance

  March 23, 2020

• FDA greenlights expanded remote patient monitoring to keep patients out of coronavirus-slammed hospitals

  March 20, 2020

• Moody's cuts medtech outlook on coronavirus upheaval

  March 18, 2020

• Endologix secures FDA approval for new abdominal stent graft

  March 17, 2020

• Value-based payment models take hold in medtech, but barriers slow shift

  March 16, 2020

• Rival to Boston Scientific device used in TAVR wins CE mark

  March 11, 2020

• FDA updates guidance on 510(k) submissions for electrosurgical devices

  March 10, 2020

• TMS pioneer Neuronetics gets breakthrough nod, CEO departs

  March 9, 2020

• Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk

  March 4, 2020

• Livongo tops Q4 estimates with contributions outside of diabetes

  March 3, 2020

• FDA seeks 'right balance' as it permits immediate use of coronavirus tests

  March 2, 2020

• FDA advises boxed warning for surgical devices half-decade after flagging cancer risk to women

  Feb. 26, 2020

• Analysis casts doubt on Boston Scientific TAVR embolic protection device

  Feb. 25, 2020

• On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging

  Feb. 24, 2020

• Battle of the 'bots: 4 robotic surgery rivalries to watch in the year ahead

  Feb. 24, 2020

• FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk

  Feb. 20, 2020

• As CMS coverage decision nears, Abbott gears for MitraClip expansion

  Feb. 18, 2020

• Wearable heart rate sensor accuracy didn't vary across skin tones in small Duke study

  Feb. 11, 2020

• Medtronic faces key test in establishing US market for renal denervation

  Feb. 10, 2020

• Contura nabs FDA nod for female incontinence device

  Feb. 4, 2020

• Its DOJ case settled, ResMed tops revenue expectations in Q2

  Feb. 3, 2020

• FDA clears Eko's stethoscope algorithms for AFib, heart murmur screening

  Jan. 29, 2020

• FDA OKs latest Medtronic leadless pacemaker, potentially tripling market

  Jan. 22, 2020

• UK health authority 'proactively' monitoring breast implant illness reports

  Jan. 21, 2020

• Amid Q4 letdown, Boston Scientific aims for $1B mark in structural heart

  Jan. 15, 2020

• Robotic surgeries surge to 15% of all procedures, despite limited evidence

  Jan. 14, 2020

• FDA guidance on catheters zeros in on testing, coatings

  Jan. 13, 2020

• Enrollment has ended in Essure postmarket study, FDA says

  Jan. 13, 2020

• FDA OKs alternative to open heart surgery for Abbott's HeartMate 3 pump

  Jan. 8, 2020

• EU group offers guidance on meeting MDR's cybersecurity standards

  Jan. 7, 2020

• Terumo subsidiary gains FDA nod for aneurysm flow diverter

  Jan. 6, 2020

• Simplified devices, pharmacy access among 2020 catalysts for diabetes tech: analysts

  Jan. 6, 2020

• FDA finalizes exemptions for certain devices from 510(k) review

  Dec. 31, 2019

• Medtech manufacturing lags pharma in emerging markets, McKinsey report says

  Dec. 23, 2019

• LivaNova recalls vagus nerve implant amid reset problems

  Dec. 23, 2019

• FDA downclassifies cranial electrotherapy stimulators for anxiety, insomnia

  Dec. 20, 2019

• AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod

  Dec. 19, 2019

• FDA warns Conformis over sterilization cycle failures

  Dec. 19, 2019

• Telehealth provider Ro to offer De Novo-winning obesity capsule

  Dec. 18, 2019

• FDA may change how it announces PMA, HDE decisions

  Dec. 17, 2019

• Dexcom CEO on remote monitoring outage: 'No excuses. We can do better'

  Dec. 16, 2019

• FDA moves to electronic premarket submissions

  Dec. 16, 2019

• FDA names Beta Bionics' pancreas tech a breakthrough device

  Dec. 11, 2019

• Abbott warns of issues with HeartMate 3 cable, mobile power unit

  Dec. 10, 2019

• House bill would speed CMS coverage for breakthrough medtech

  Dec. 9, 2019

• FDA proposes alternative 510(k) criteria for MRI coils

  Dec. 9, 2019

• Company of the Year: Edwards Lifesciences

  Dec. 9, 2019

• Sens. Wyden, Booker push CMS, FTC, insurers on bias in algorithms

  Dec. 4, 2019

• Feds charge lab owner in latest genetic testing kickback scheme

  Dec. 2, 2019

• FDA seeks public input on pediatric device applications including ways to minimize burden

  Dec. 2, 2019

• GE Healthcare bulks up in 3D printing, robotics, patient monitoring

  Dec. 2, 2019

• Boston Heart to pay $26.7M to settle alleged doctor kickback scheme

  Nov. 27, 2019

• Standards body urged to add device identifiers to insurance claims forms

  Nov. 26, 2019

• Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis

  Nov. 25, 2019

• FDA flags 2 more deaths, over 60 device failures tied to heart balloon pump

  Nov. 20, 2019

• FDA approves 1st contact lens to slow myopia in children

  Nov. 19, 2019

• Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations

  Nov. 18, 2019

• Qiagen in talks with potential buyers amid weak results, restructuring

  Nov. 18, 2019

• Nascent digital therapeutics group defines best practices, ethics code

  Nov. 13, 2019

• Medtronic's Micra AV pacemaker meets study goals, submitted for FDA review

  Nov. 12, 2019

• Wright Medical growth slowed in run-up to Stryker deal

  Nov. 11, 2019

• Medtronic, Boston issue paclitaxel data in rebuff to safety worries

  Nov. 6, 2019

• As Essure implant return deadline nears, FDA study enrollment inches up

  Nov. 5, 2019

• 5 breakthrough devices qualify under finalized faster outpatient payment path

  Nov. 4, 2019

• Medtronic developing fully implanted LVAD with FDA breakthrough support

  Oct. 30, 2019

• FDA again warns of leak risk with Endologix AAA grafts

  Oct. 29, 2019

• Abiomed says right-heart pump protocol boosts survival in postmarket data

  Oct. 28, 2019

• TAVR momentum lifts Edwards' Q3 results, beating estimates

  Oct. 24, 2019

• FDA expands MDIC quality pilot to non-compliant manufacturers

  Oct. 22, 2019

• Sleep apnea testing shifts to the home, survey suggests

  Oct. 21, 2019

• Medtronic rolls out AI-assisted colonoscopy system in Europe

  Oct. 21, 2019

• FDA warns dental X-ray supplier over radiation exposure reporting

  Oct. 16, 2019

• California bill to end excessive dialysis profits becomes law

  Oct. 15, 2019

• Smartphone health coaching gets some people moving, study says

  Oct. 14, 2019

• FDA pushes back against criticism of third party 510(k) review

  Oct. 14, 2019

• Medtronic recalls more than 100K guide catheters for fragment risk

  Oct. 9, 2019

• Teleflex recalls GaleMed infant breathing device it distributed

  Oct. 9, 2019

• From robots to staplers, a top 10 list of medtech safety hazards

  Oct. 8, 2019

• Abbott pulling ahead in glucose monitoring race: UBS doc survey

  Oct. 7, 2019

• Mechanical thrombectomy market poised to double: analysts

  Oct. 7, 2019

• Venture capital investing in digital health cools in Q3: report

  Oct. 2, 2019

• Third-party software vulnerability could endanger medical devices, FDA and DHS warn

  Oct. 2, 2019

• Robotics, navigation systems create buzz at spine meeting

  Oct. 1, 2019

• Edwards shows improved quality of life, durability of TAVR systems in trio of studies

  Sept. 30, 2019

• Abbott's MitraClip outperforms medical therapy in study at 3 years

  Sept. 30, 2019

• Medtronic plans to answer da Vinci with rival soft tissue robot

  Sept. 25, 2019

• Medtronic updates Evolut TAVR system, gains FDA nod

  Sept. 23, 2019

• FDA lays out vision for device conformity testing pilot

  Sept. 23, 2019

• Manufacturer modifies wheelchair for off-roading, draws FDA warning

  Sept. 18, 2019

• Wright Medical's Cartiva woes will take time to fix: analysts

  Sept. 17, 2019

• Chronic bronchitis device wins breakthrough designation

  Sept. 17, 2019

• Zimmer Biomet's Rosa Brain recall categorized as Class I

  Sept. 17, 2019

• Varian buys software developer for AI cancer work

  Sept. 16, 2019

• Nurses, physician assistants rarely interpret diagnostic images, study finds

  Sept. 16, 2019

• FDA finalizes 4 guidances to clarify 510(k) pathways

  Sept. 13, 2019

• Baxter puts up $230M for noninvasive fluid monitor company

  Sept. 11, 2019

• Abbott says AI technology can help diagnose heart attacks

  Sept. 11, 2019

• Medtronic MiniMed insulin pump gains German reimbursement

  Sept. 10, 2019

• Zimmer gets 510(k) clearance for Persona Revision knee

  Sept. 10, 2019

• Hospital buying data point to TAVR surge in Q3: analysts

  Sept. 9, 2019

• Pulmonary arterial hypertension device wins FDA breakthrough designation

  Sept. 9, 2019

• FDA finalizes guidance for accepting De Novo requests

  Sept. 9, 2019

• FDA finalizes guidance on HDEs after AdvaMed scrutiny

  Sept. 6, 2019

• Tool to bust coronary plaque with sonic waves wins FDA breakthrough nod

  Sept. 4, 2019

• Imaging test usage is reaccelerating, JAMA study finds

  Sept. 4, 2019

• Conformis sues Zimmer Biomet over patent infringement

  Aug. 20, 2019

• Fusion-less scoliosis device from Zimmer Biomet earns HDE

  Aug. 19, 2019

• FDA approves neuromodulation device for heart failure

  Aug. 19, 2019

• V-Wave gets 2nd breakthrough designation for interatrial shunt

  Aug. 16, 2019

• FDA hits medicine cabinet and cart maker Talon with warning letter

  Aug. 14, 2019

• Analysts predict big jump in continuous glucose monitor use

  Aug. 14, 2019

• Stryker acquires maker of device sterilization systems

  Aug. 13, 2019

• Australia weighs in on paclitaxel-coated balloons

  Aug. 13, 2019

• Blood test to detect breast cancer recurrence, guide treatment, shows promise in small study

  Aug. 12, 2019

• Ambu to pay $3.3M to settle False Claims Act allegations

  Aug. 12, 2019

• NuVasive looks to tech pipeline, overseas expansion in bid for spine market share

  Aug. 12, 2019

• UBS surgeon poll points to neuromodulation market slowdown

  Aug. 9, 2019

• Guardant Q2 sales soar on liquid biopsy adoption

  Aug. 7, 2019

• Abbott recommends removal of certain ICDs due to exposed wires

  Aug. 6, 2019

• BD: FDA says Lutonix paclitaxel balloon not approvable for below the knee

  Aug. 6, 2019

• VA software workarounds put patient data at risk: OIG

  Aug. 5, 2019

• B. Braun gets breakthrough status for paclitaxel-coated balloon catheter

  Aug. 5, 2019

• FDA extends comment period for draft guidance on magnetic resonance safety

  Aug. 5, 2019

• FDA announces fiscal 2020 device user fee rates

  July 31, 2019

• Slow spine market growth to persist as insurers push back, UBS survey suggests

  July 31, 2019

• Mayo, Boston Scientific deepen ties with medtech accelerator launch

  July 30, 2019

• Humana accuses Abbott of duping it to pay to remove dodgy heart devices

  July 30, 2019

• ResMed discloses tentative DOJ settlement, sets aside $41.2M

  July 29, 2019

• Australia on watch for possible EU notified body shortage

  July 29, 2019

• New delivery system for sinus stent gains FDA approval

  July 29, 2019

• Stryker says Mako robot driving orthopaedic share gains

  July 26, 2019

• PCORI, MD Anderson team up on lung cancer screening aid

  July 24, 2019

• Walgreens adds Dexcom, Propeller to digital marketplace

  July 24, 2019

• FDA grants first cochlear implant indication for asymmetric hearing loss

  July 23, 2019

• FDA sets final guidance on combo product safety reporting

  July 23, 2019

• HER2 breast cancer imaging tech gets breakthrough nod

  July 22, 2019

• Random plasma glucose testing helps predict diabetes in large VA study

  July 22, 2019

• Burst balloons prompt safety alert on Edwards Sapien 3 Ultra valve system

  July 22, 2019

• Most hospitals don't meet watchdog group's safe volume thresholds for high-risk surgeries

  July 18, 2019

• FDA warns of risks when shunt implants, hearing devices mix

  July 17, 2019

• Abbott's latest MitraClip version gains FDA approval

  July 16, 2019

• Bayer MRI contrast agent gets nod for coronary artery disease

  July 16, 2019

• GE recalls infant warmers due to panel, latch cracks

  July 15, 2019

• Ventilator software error prompts Hamilton Medical recall

  July 15, 2019

• Screenings fail to explain rise in colorectal cancer in younger adults, study finds

  July 15, 2019

• CRT wheelchair protection passes House Energy & Commerce Committee

  July 12, 2019

• Edwards poised for a Q2 TAVR rebound, analysts predict

  July 10, 2019

• WHO expands lists of essential in vitro diagnostics

  July 10, 2019

• Medtronic HVAD shows low stroke risk in study of thoracotomy approach

  July 9, 2019

• Feds warn of cyber vulnerability in hospital anesthesia machines

  July 9, 2019

• Edwards issues safety notice for Centera valve after reports of injury, death

  July 8, 2019

• Insulin pen smart cap maker in talks to supply Sanofi

  July 8, 2019

• Spanish agency steps up to become an MDR notified body

  July 8, 2019

• Wright Medical shares tumble amid report of Cartiva slowdown

  July 3, 2019

• FDA patient advisory meeting set to tackle cybersecurity in devices

  July 3, 2019

• As digital health investing matures, report says sector dodges a bubble

  July 2, 2019

• FDA responds to feedback on De Novo classification requests

  July 2, 2019

• Military-focused abdominal trauma foam earns FDA breakthrough status

  July 1, 2019

• House lawmakers introduce bill to delay PAMA data collection

  July 1, 2019

• Boston Scientific says Watchman more cost effective than drugs for AFib

  July 1, 2019

• Interagency workshop to focus on device interoperability

  June 28, 2019

• Jejunostomy tube manufacturer draws FDA warning letter

  June 26, 2019

• FDA offers guidance on data for prostate ablation devices

  June 26, 2019

• MRI as safe as cardiac catheterization for coronary disease screening: NEJM

  June 25, 2019

• Mayo Clinic to build proton therapy facility on Florida campus

  June 25, 2019

• Hologic moves to acquire French ultrasound company

  June 24, 2019

• Teleflex recalls more endotracheal tubes, now linked to four deaths

  June 24, 2019

• Final TAVR Medicare decision gets thumbs up from Edwards, Medtronic

  June 24, 2019

• NIH's Collins highlights progress on 3D printed human organs

  June 21, 2019

• Bursting balloon catheters prompt Cook Medical recall

  June 19, 2019

• Foam to stop abdominal bleeding gets FDA breakthrough nod

  June 19, 2019

• FDA approves cochlear implant designed for MRI

  June 18, 2019

• Bio-Techne gains breakthrough status for liquid biopsy prostate test

  June 18, 2019

• FDA 'white hat' hacking tools may combat medical misinformation

  June 17, 2019

• Health Canada seeks advice on device action plan next steps

  June 17, 2019

• SaMD will increase device innovation: Fitch

  June 17, 2019

• Many in need of knee cartilage repair excluded from studies, researchers say

  June 14, 2019

• Antibiotic resistance test for gonorrhea gets FDA breakthrough nod

  June 12, 2019

• Inhaler monitoring lowers COPD hospitalizations in small study

  June 12, 2019

• EU names UDI issuers in move to new medtech regs

  June 11, 2019

• Pathology group sets expectations for DTC genetic tests

  June 11, 2019

• Stimulation device for IBS pain in children gains De Novo clearance

  June 10, 2019

• Medtech avoids tariff blow as US, Mexico reach deal

  June 10, 2019

• Harvard's Wyss Institute receives $131M gift

  June 10, 2019

• Concussion test gets breakthrough nod in fast-growing field

  June 7, 2019

• Apple Watch, mesh slings among new NESTcc projects

  June 5, 2019

• Muscle relaxation app helps calm migraine in small NYU study

  June 5, 2019

• Donor lung preservation system gains expanded indication

  June 4, 2019

• OIG issues alert on genetic testing scam

  June 4, 2019

• Multi-cancer blood test shows early promise at ASCO

  June 3, 2019

• Device makers could feel pinch from Mexico tariffs

  June 3, 2019

• Roche, GE Healthcare partner on software for tumor boards

  June 3, 2019

• Wearable glucose monitor wins CE mark, as market gets crowded

  May 31, 2019

• Test for Parkinson's wins FDA breakthrough designation

  May 29, 2019

• Qiagen launches companion test for Novartis breast cancer treatment

  May 29, 2019

• Neurostimulators could be good match for stroke patients, study suggests

  May 28, 2019

• FDA clears endoscope connector to prevent fluid backflow

  May 28, 2019

• Neuromodulation patch for migraine gains De Novo nod

  May 28, 2019

• Extragenital tests for chlamydia and gonorrhea get FDA nod

  May 24, 2019

• FDA on Abiomed right heart device: patient selection is key

  May 22, 2019

• Abbott releases 30-day data on tricuspid valve repair system

  May 22, 2019

• Stryker wins approval for brain aneurysm stent system

  May 21, 2019

• J&J's Auris unveils early results on Monarch robot for lung procedures

  May 21, 2019

• FDA warns diabetes patients against use of unauthorized devices

  May 20, 2019

• Philadelphia jury awards $80M in J&J pelvic mesh suit

  May 20, 2019

• Ra Medical files suit alleging rival interfered with IPO

  May 20, 2019

• Canada raises medical device regulatory fees

  May 17, 2019

• Abbott, NIH collaborate on neuroscience research

  May 15, 2019

• Haemonetics sells plant, gains expanded indication for blood analyzer systems

  May 15, 2019

• CMS will weigh broader mitral valve repair NCD, analysts predict

  May 14, 2019

• Same-day upper and lower endoscopies improve care, costs: JAMA

  May 14, 2019

• Medtronic, Boston Scientific unveil ICD data

  May 13, 2019

• LabCorp to sell Qiagen companion diagnostic for bladder cancer

  May 13, 2019

• Medicare contractors finalize narrow coverage for glioblastoma treatment

  May 13, 2019

• Eye scan to detect Alzheimer's biomarker gets breakthrough status

  May 10, 2019

• FDA warns of rapid battery draining in some Medtronic pacemakers

  May 8, 2019

• FDA updates imaging rules in final guidance

  May 8, 2019

• Test for circulating tumor DNA wins FDA breakthrough designation

  May 7, 2019

• FDA issues final guide on device submission meetings, feedback

  May 7, 2019

• Test for gene fusions in tumors gains breakthrough status

  May 6, 2019

• FDA OKs Staar Surgical clinical study initiation after PMA supplement holdup

  May 6, 2019

• EU issues device, diagnostics database requirements

  May 6, 2019

• AI diagnostic tool for kidney disease earns breakthrough status

  May 3, 2019

• CMS approves Livongo as Medicare Advantage provider

  May 1, 2019

• Plastic surgery device maker draws FDA warning letter

  May 1, 2019

• Device to preserve donor lungs wins FDA approval

  April 30, 2019

• CMS reopens coverage determination on next generation sequencing for cancer patients

  April 30, 2019

• UK issues alert on risks with J&J surgical stapler

  April 29, 2019

• Edwards recalls two heart catheters used in infants

  April 29, 2019

• Cardiology groups oppose CMS policy shift on TAVR volume

  April 29, 2019

• FDA publishes guidance on device performance bench tests

  April 26, 2019

• FDA pitches stronger controls, new labeling for surgical staplers

  April 24, 2019

• Edwards Lifesciences beats profit forecasts amid low-risk TAVR momentum

  April 24, 2019

• Study supports genetic testing for sudden cardiac arrest

  April 23, 2019

• Obesity device to slow stomach emptying gets approval

  April 23, 2019

• More patients die after starting dialysis than registry suggests: Harvard study

  April 23, 2019

• FDA wants details on nitinol in premarket device applications

  April 22, 2019

• FDA drafts premarket recommendations for quantitative medical imaging

  April 22, 2019

• CDC rule removes barrier to sale of escape respirators

  April 22, 2019

• Brainlab recalls spine 3D navigation software for incorrect display

  April 17, 2019

• AI poised to 'transform' medical imaging, radiology society says

  April 17, 2019

• FDA approves post-angioplasty dissection repair device

  April 16, 2019

• Edible hydrogel capsule to treat obesity gets FDA go-ahead

  April 16, 2019

• Contaminated duodenoscopes linked to 3 new deaths, 45 more infections, FDA says

  April 15, 2019

• FDA flags breathing tube shortage tied to sterilization plant closing

  April 15, 2019

• AliveCor's AI software for EKG rhythms gets market OK

  April 15, 2019

• Avinger's image-guided device for PAD gets FDA nod

  April 11, 2019

• Prices soar for new medtech, but payment lags: report

  April 10, 2019

• Pfizer, Concerto collaborate on AI in precision oncology

  April 10, 2019

• FDA warns patients to steer clear of pre-owned test strips

  April 9, 2019

• Medtronic, Blue Cross strike value-based pact for glucose monitors

  April 9, 2019

• Abiomed reports improved survival rates in cardiogenic shock patients

  April 8, 2019

• Nvidia, American College of Radiology partner on AI platform

  April 8, 2019

• Medtronic analysis tracks reduced strokes in HVAD patients

  April 8, 2019

• Saturated oxygen treatment for heart attack wins FDA approval

  April 5, 2019

• Disposable spinal rod strain sensor earns De Novo clearance

  April 3, 2019

• FDA greenlights study of breakthrough device to treat aggressive pancreatic cancer

  April 3, 2019

• Channel Medsystems' endometrial cryoablation device gets FDA nod

  April 2, 2019

• FDA gives PMA to injection treatment for knee pain

  April 2, 2019

• FDA repeals some regs on radiation-emitting devices

  April 1, 2019

• CMS to tackle lab payments codes in pair of public meetings

  April 1, 2019

• FDA finalizes rules for anthrax bacteria tests, spine devices

  April 1, 2019

• ECRI Institute launching international device testing lab

  March 29, 2019

• Sterilizer plant shutdown prompts FDA action on device shortages

  March 27, 2019

• FDA clears Zimmer robot that combines brain, spine, knee functionality

  March 27, 2019

• CMS greenlights LivaNova's protocol for depression device trial

  March 26, 2019

• CMS due to release updated TAVR coverage determination

  March 26, 2019

• Biomagnetic imaging for chest pain wins FDA clearance

  March 25, 2019

• Not even money prods patients to mail-in colon tests, study suggests

  March 25, 2019

• EU device group wants clarity on expert panels under MDR

  March 25, 2019

• FDA approves first-of-its-kind heart failure device

  March 22, 2019

• Alzheimer's device De Novo on the line at FDA panel

  March 20, 2019

• FDA warns Sientra, J&J's Mentor on lax post-approval breast implant studies

  March 20, 2019

• BD wins PMA for stent treating venous occlusive disease

  March 19, 2019

• FDA outlines new device priorities in budget justification report

  March 19, 2019

• FDA: Avoid paclitaxel-coated PAD devices for most patients

  March 18, 2019

• TAVR called 'game changing' in studies of low-risk patients

  March 18, 2019

• Intuitive's da Vinci SP gets FDA otolaryngology clearance

  March 18, 2019

• Abbott gains expanded indication for MitraClip valve repair device

  March 15, 2019

• FDA qualifies test for traumatic brain injury

  March 13, 2019

• Smith & Nephew buys skin substitute maker for $660M

  March 13, 2019

• Intrathecal drug delivery system wins FDA breakthrough designation

  March 12, 2019

• Edwards deepens structural heart position with new investments

  March 12, 2019

• FDA flags surgical stapler risks, plans advisory meeting

  March 11, 2019

• TAVR for low-risk patients in spotlight at ACC

  March 11, 2019

• AdvaMed raises concerns with FDA's proposed De Novo model

  March 11, 2019

• AI tool for cancer diagnosis wins FDA breakthrough status

  March 8, 2019

• Ascension hospital network taps Abbott diagnostics for lab work

  March 6, 2019

• Device to detect internal bleeding wins De Novo clearance

  March 5, 2019

• Masimo brain monitor gets CE mark pediatric indication

  March 5, 2019

• Blood test identifies proteins to predict preterm birth

  March 4, 2019

• Medtronic says corrected IN.PACT analysis to be published in JACC

  March 4, 2019

• Scientists propose universal standard to calibrate CT scanners

  March 4, 2019

• Gene test for antibiotic resistance gets FDA breakthrough nod

  March 1, 2019

• Medtronic Resolute stent gains expanded indication

  Feb. 27, 2019

• Thermo Fisher lung cancer test wins expanded approval in Japan

  Feb. 27, 2019

• FDA warns breast infrared imaging tool should not replace mammography

  Feb. 26, 2019

• Verily launches eye disease screening algorithm in India

  Feb. 26, 2019

• Swiss regulator weighs in on textured breast implants

  Feb. 20, 2019

• Intuitive gains FDA clearance for Ion lung catheter

  Feb. 20, 2019

• FDA proposes new channel for giving feedback on inspections

  Feb. 19, 2019

• FDA clarifies pathway for devices used in regenerative medicine

  Feb. 19, 2019

• Medtronic recalls pacemakers due to software error

  Feb. 19, 2019

• FDA orders doctor to stop marketing unapproved breast augmentation device

  Feb. 15, 2019

• Breast implants face increased safety scrutiny in Canada

  Feb. 13, 2019

• Edwards Lifesciences buys maker of brain oxygen monitor

  Feb. 13, 2019

• Rapid test for brain injury gets FDA breakthrough status

  Feb. 12, 2019

• Device to prevent spinal disc herniation wins PMA after setback

  Feb. 12, 2019

• Device that extracts brain tumors gains FDA breakthrough status

  Feb. 11, 2019

• FDA finalizes guidance to strengthen its recall processes

  Feb. 11, 2019

• Mayo, Intermountain set partnerships for new tech hubs

  Feb. 11, 2019

• Teleflex granted FDA approval for vascular closure device

  Feb. 6, 2019

• BD results largely expected, beats on revenue

  Feb. 5, 2019

• Healthcare groups urge CMS to keep coverage of NGS cancer tests

  Feb. 5, 2019

• Cook Medical aortic dissection device gets FDA approval

  Feb. 5, 2019

• Oxipit AI-based tool for chest X-ray analysis gets CE mark

  Feb. 4, 2019

• FDA announces warfarin test strips, IV fluid transfer systems recalls

  Feb. 4, 2019

• Stryker issues voluntary field action after 6 deaths linked to defibrillator bug

  Feb. 4, 2019

• Edwards' sales on track, but outlook cautious

  Feb. 1, 2019

• Cybersecurity device plan seeks alignment of industry, regulators

  Jan. 30, 2019

• Stryker impresses in Q4, sets bold forecasts

  Jan. 30, 2019

• J&J data suggests its stapler reduces more lung surgery air leaks than competitor

  Jan. 29, 2019

• FDA sets March date for breast implant panel meeting

  Jan. 29, 2019

• Draeger Medical recalls single-use breathing circuits

  Jan. 28, 2019

• ResMed Q2 revenue miss sends shares plunging

  Jan. 28, 2019

• Zimmer Biomet gets 510(k) for robotic knee surgery system

  Jan. 28, 2019

• Intuitive Surgical to step up investment outside the US

  Jan. 25, 2019

• Medtronic data show no paclitaxel-mortality link amid FDA warnings

  Jan. 23, 2019

• Illumina TruSight assay gets FDA breakthrough designation

  Jan. 23, 2019

• M&A, robotics among medtech growth drivers for 2019: Moody's

  Jan. 22, 2019

• Verily Study Watch gets FDA nod for EKG

  Jan. 22, 2019

• Bigfoot could shake up insulin delivery market, analyst says

  Jan. 22, 2019

• FDA flags mortality risk of paclitaxel with stents, balloons for PAD

  Jan. 18, 2019

• FDA clears energy tools for TransEnterix robotic surgery system

  Jan. 16, 2019

• Medtronic links patients' pacemakers with their smartphones

  Jan. 16, 2019

• Abbott heart device for premature babies wins FDA approval

  Jan. 15, 2019

• FDA clears absorbable foot and ankle implant

  Jan. 15, 2019

• Jefferies predicts upbeat 2019 medtech outlook

  Jan. 14, 2019

• Mobile and wearable data increasingly useful to patients, JAMA authors say

  Jan. 14, 2019

• FDA grants breakthrough designation to wearable dialysis device

  Jan. 14, 2019

• FDA to beef up Sentinel postmarket electronic safety system

  Jan. 11, 2019

• Medical records key to Apple health strategy: report

  Jan. 9, 2019

• Medtronic recalls imaging software used in brain surgery

  Jan. 9, 2019

• Hologic boosts its first-quarter revenue outlook

  Jan. 8, 2019

• TransEnterix forecasts revenue growth, sells more robots

  Jan. 8, 2019

• Endologix recalls Nellix aneurysm sealing system

  Jan. 7, 2019

• AI with EKG can detect a form of heart disease, research shows

  Jan. 7, 2019

• Hospitals gain leverage on medical device pricing: report

  Jan. 7, 2019

• LabCorp inks licensing pact for Genfit liver test

  Jan. 4, 2019

• CMS sets user fee increase for CLIA-certified labs

  Dec. 31, 2018

• GAO: DME supplier pool shrinks under competitive bidding

  Dec. 26, 2018

• Health Canada unveils plan to improve medical device safety

  Dec. 21, 2018

• UK regulator puts brakes on Thermo Fisher-Gatan deal

  Dec. 20, 2018

• Aortic stent graft market on path to solid growth

  Dec. 19, 2018

• Cardiva wins FDA approval for its vascular closure system

  Dec. 19, 2018

• Medtronic wins FDA OK for InterStim smart programmer

  Dec. 18, 2018

• OIG: Medicare contractor overpaid hospitals for radiation treatments

  Dec. 18, 2018

• FDA addresses manufacturing site changes in final guidance

  Dec. 17, 2018

• FDA draft guidance aims to clarify X-ray radiation rules

  Dec. 17, 2018

• Nonprofit gets boost to realize automated insulin delivery app

  Dec. 17, 2018

• Rapid diagnostic test detects Ebola, malaria in the field

  Dec. 14, 2018

• UK readies 'worst-case' Brexit plan for medical devices

  Dec. 12, 2018

• HIMSS: Health coaching could boost value of wearables

  Dec. 12, 2018

• Thermo Fisher gets FDA nod for plazomicin immunoassay

  Dec. 11, 2018

• Hologic begins selling 3-in-1 uterine scope

  Dec. 11, 2018

• Cybersecurity priorities laid out by key House panel

  Dec. 10, 2018

• FDA clears Contego Medical peripheral angioplasty system

  Dec. 10, 2018

• FDA to revisit transvaginal mesh issues at February meeting

  Dec. 10, 2018

• Device industry 2019 outlook beats hospitals, pharma: Moody's

  Dec. 7, 2018

• ResMed buys maker of COPD, asthma monitoring platform

  Dec. 5, 2018

• FDA endorses open database for genetic variants

  Dec. 5, 2018

• Medtronic AFib study combines hot, cold ablation techniques

  Dec. 4, 2018

• Medtech R&D adapting under new pressures, industry study shows

  Dec. 4, 2018

• Medicare could overpay billions for lab tests: GAO

  Dec. 3, 2018

• FDA OKs first test to detect herpes in newborns

  Dec. 3, 2018

• LabCorp cuts its profit outlook, citing volume shortfall

  Dec. 3, 2018

• FDA issues draft guidance on blood glucose monitors

  Nov. 30, 2018

• Zimmer Biomet recalls spine fusion, bone growth stimulators

  Nov. 28, 2018

• Quest closes buy of Midwest lab services business

  Nov. 28, 2018

• Reprocessor receives FDA clearance for 4 catheters

  Nov. 27, 2018

• Pacing leads recalled for potential connector separation

  Nov. 27, 2018

• Medtronic buys nutrition data startup for diabetes care

  Nov. 26, 2018

• FDA details ramp-up of postmarket device oversight

  Nov. 21, 2018

• Scientists unveil first 3D images from new whole-body scanner

  Nov. 21, 2018

• Medtronic posts strong Q2 on diabetes, pain management

  Nov. 20, 2018

• New Philips ventilator combines two modes in one device

  Nov. 20, 2018

• FDA plan would ease regulations for prescription drug apps

  Nov. 20, 2018

• Edwards Lifesciences gets CE mark for advanced heart valve

  Nov. 19, 2018

• Medtronic aneurysm repair device proves durable in complex cases

  Nov. 19, 2018

• Boston Scientific to spend over $200M in restructuring

  Nov. 19, 2018

• GE Healthcare recalls nuclear medicine imaging systems

  Nov. 16, 2018

• Owens & Minor names interim chairman and CEO

  Nov. 9, 2018

• Long-term data backs Medtronic drug-coated balloon for PAD

  Nov. 7, 2018

• FDA clears Siemens Healthineers mobile 3D imaging arm

  Nov. 7, 2018

• Becton Dickinson Q4 revenue up, some Wall Street misses

  Nov. 6, 2018

• FDA approves 2 devices to aid in thyroid surgery

  Nov. 5, 2018

• Pact to rush medical products for military clinched

  Nov. 5, 2018

• FDA extends time to comply on unique device identification

  Nov. 5, 2018

• FDA deficient on device cybersecurity readiness, watchdog says

  Nov. 2, 2018

• NuVasive CEO says spine industry poised to consolidate

  Oct. 31, 2018

• Baxter earns CE mark for new renal replacement system

  Oct. 30, 2018

• Genentech releases more data on refillable eye implant

  Oct. 30, 2018

• FDA panel to review first-of-a-kind heart failure device

  Oct. 29, 2018

• Philips launches all-in-one breast ultrasound product

  Oct. 29, 2018

• Drug-delivery device developer snags Sanofi as investor

  Oct. 29, 2018

• Stryker touts benefits of Mako robot on knee outcomes, costs

  Oct. 26, 2018

• Edwards Lifesciences Q3 sales up 10%

  Oct. 24, 2018

• Quest disappoints with full year revenue forecast cut

  Oct. 23, 2018

• Heater-cooler device redesigned to limit infections: FDA

  Oct. 22, 2018

• Abbott HeartMate 3 gets OK as transplant alternative

  Oct. 22, 2018

• Stryker asks to extend anti-trust deadline for K2M deal

  Oct. 22, 2018

• Intuitive Surgical sees 20% growth in da Vinci robot use

  Oct. 19, 2018

• FDA clears Pfizer PARP drug, Myriad companion test for breast cancer

  Oct. 17, 2018

• Medtronic sells workflow tool to boost its opioid pump

  Oct. 17, 2018

• J&J posts softer Q3 device sales

  Oct. 16, 2018

• Health apps require robust regulatory approach: JAMA opinion

  Oct. 15, 2018

• CT scans can diagnose complex heart disease, study shows

  Oct. 15, 2018

• FDA to fund pediatric medical device consortium

  Oct. 15, 2018

• TransEnterix wins FDA nod for smaller robotic instruments

  Oct. 12, 2018

• FDA OKs DNA-based test for blood transfusion compatibility

  Oct. 12, 2018

• RightEye's eye-tracking system gets FDA clearance

  Oct. 10, 2018

• Siemens' latest 1.5T MRI scanner gets FDA nod

  Oct. 10, 2018

• Researchers develop biodegradable nerve stimulation device

  Oct. 9, 2018

• Eximo Medical gains FDA clearance for atherectomy laser

  Oct. 9, 2018

• 1 in 5 health IT execs say malware has hit devices

  Oct. 8, 2018

• Bose self-fitting hearing aid gets FDA approval

  Oct. 8, 2018

• Prostate cancer imaging agent meets one of two study endpoints

  Oct. 8, 2018

• Fitbit rolling out Charge 3 with focus on sleep tracking

  Oct. 5, 2018

• Baxter, Mayo team up on outpatient kidney care center

  Oct. 3, 2018

• Artificial pancreas has edge over insulin pump therapy in study

  Oct. 3, 2018

• Stryker settles foreign corrupt practice charges, makes small acquisition

  Oct. 2, 2018

• FDA, ECRI, device group keep up drumbeat on cybersecurity risks

  Oct. 2, 2018

• FDA finds fault with some insulin pen use directions

  Oct. 1, 2018

• Doctor survey finds strong interest in new urology devices

  Oct. 1, 2018

• FDA clears NGS test to detect residual blood cancer cells

  Oct. 1, 2018

• Hologic acquires developer of breast cancer surgery marker

  Sept. 28, 2018

• Global device industry set to grow 5.6% a year through 2024: report

  Sept. 26, 2018

• Medtronic launches Infinity spine fusion system

  Sept. 26, 2018

• Medtronic CoreValve proves durable in longer-term data

  Sept. 25, 2018

• FDA gives final guidance on device benefits, risks in 510(k) submissions

  Sept. 25, 2018

• Boston Scientific's Eluvia wins FDA nod, seen as effective as Cook's Zilver in study

  Sept. 24, 2018

• Medtronic heart stent works as well as thin-strut Orsiro: study

  Sept. 24, 2018

• Abbott's MitraClip keeps more heart valve patients alive in study

  Sept. 24, 2018

• Medicare lab test spending up slightly in 2017: OIG

  Sept. 21, 2018

• Medtronic to study TAVR in low-risk bicuspid patients

  Sept. 19, 2018

• Ra Medical amends IPO plan

  Sept. 19, 2018

• AI can identify lung cancer types in images, study finds

  Sept. 18, 2018

• NIH funds study of artery imaging without contrast dyes

  Sept. 18, 2018

• Stent to seal coronary artery perforations gets FDA nod

  Sept. 17, 2018

• FDA defends its work on breast implant safety

  Sept. 17, 2018

• FDA tests new way to shorten 510(k) review times

  Sept. 17, 2018

• Gottlieb: FDA pursuing faster approval path for diagnostics

  Sept. 14, 2018

• FDA advised to step up device cybersecurity checks premarket

  Sept. 12, 2018

• Companion diagnostic for bile duct cancer treatment in works

  Sept. 12, 2018

• A call to make EHRs safer for pediatric patients

  Sept. 11, 2018

• Medtronic to study one month of DAPT in high-bleeding-risk patients

  Sept. 11, 2018

• FDA raises concerns about feeding tube misconnections

  Sept. 10, 2018

• Becton Dickinson sells bioprocessing business to Thermo Fisher

  Sept. 10, 2018

• Bundled payment model cuts joint replacement costs in study

  Sept. 10, 2018

• FDA clears new version of Baxter bone graft substitute

  Sept. 7, 2018

• Livongo adds continuous glucose data via Abbott's FreeStyle Libre

  Sept. 7, 2018

• Developing afib after valve implant raises risks, study finds

  Sept. 5, 2018

• Cigna names chief data and analytics officer

  Sept. 5, 2018

• Otsuka rolls out Abilify digital pill through Magellan network

  Sept. 4, 2018

• European Society of Cardiology endorses iFR in guidelines

  Sept. 4, 2018

• Stryker buys spine device maker K2M for $1.4B

  Aug. 31, 2018

• Medtronic cryoballoon reduces persistent afib symptoms in study

  Aug. 31, 2018

• SynCardia stands behind its artificial heart driver

  Aug. 29, 2018

• Balloons as effective as stents to open small arteries, study says

  Aug. 29, 2018

• FDA warns Zimmer Biomet about quality violations at Indiana plant

  Aug. 28, 2018

• Medication reminder apps for heart patients could save lives, study says

  Aug. 28, 2018

• DexCom acquires maker of insulin dosing algorithm

  Aug. 27, 2018

• Patients getting needed supplies under DME bidding: GAO

  Aug. 27, 2018

• Hands-free device may track astronauts' vital signs in space

  Aug. 27, 2018

• Robotic surgery market is about to get crowded, report says

  Aug. 24, 2018

• FDA approves Keytruda companion test for bladder cancer

  Aug. 22, 2018

• NIST offers guide to securing wireless infusion pumps

  Aug. 22, 2018

• Diabetes, heart device sales drive strong Medtronic Q1

  Aug. 21, 2018

• Doctors often fail to list conflicts in device studies: JAMA report

  Aug. 20, 2018

• Noninvasive magnetic stimulation for OCD wins FDA nod

  Aug. 20, 2018

• FDA finds higher death, stroke rates for latest SynCardia artificial heart driver

  Aug. 20, 2018

• Early A1C test may reduce gestational diabetes risk: NIH study

  Aug. 17, 2018

• Healthix switching software vendors for patient matching

  Aug. 15, 2018

• Maryland failed to secure its Medicaid data: OIG

  Aug. 15, 2018

• BARDA, J&J team to crowdsource respiratory device ideas

  Aug. 14, 2018

• FDA approves one-year contraceptive ring

  Aug. 14, 2018

• NuVasive, Siemens partner on spine surgery imaging

  Aug. 13, 2018

• Most recalled foot, ankle devices are 501(k) approved, study finds

  Aug. 13, 2018

• FDA OKs marketing of contraceptive app

  Aug. 13, 2018

• Medtronic begins study of ICD with leads outside the heart

  Aug. 10, 2018

• Burn treatment earns expanded compassionate use approval

  Aug. 10, 2018

• MDLive, Beacon partner on virtual behavioral health visits

  Aug. 8, 2018

• Senseonics rolls out 90-day continuous glucose monitoring

  Aug. 8, 2018

• New blood test can rule out heart attack faster

  Aug. 7, 2018

• Varian acquires maker of patient monitoring system

  Aug. 7, 2018

• Cardinal Health posts Q4 loss as Cordis struggles

  Aug. 6, 2018

• FCC seeks comments on $100M telehealth pilot

  Aug. 6, 2018

• Abbott device to treat Parkinson's now MRI-compatible

  Aug. 3, 2018

• FDA approves Medtronic implant for rare form of hypertension

  Aug. 1, 2018

• CSI, Aerolase partner on laser atherectomy device

  Aug. 1, 2018

• FDA warns about vaginal 'rejuvenation' device claims

  July 31, 2018

• CMS advisers split on procedure volume rules for TAVR

  July 30, 2018

• FDA sets 2019 medical device user fee rates

  July 30, 2018

• FDA approves Abbott's blood sugar sensor for 14-day use

  July 30, 2018

• CMS pitches covering cardiac catheterization at surgical centers

  July 30, 2018

• FDA gives draft guidance on atherectomy device submissions

  July 27, 2018

• Stryker says Q2 tops goals, will stick to M&A playbook

  July 25, 2018

• Quest Diagnostics posts slight Q2 revenue miss

  July 24, 2018

• Bayer to stop selling Essure birth control implant in US

  July 23, 2018

• NIH center makes public a trove of CT images for research

  July 23, 2018

• Tendyne investors sue Abbott over lost milestone payment

  July 23, 2018

• Intuitive Surgical profit up on strong da Vinci robot sales

  July 20, 2018

• Calls to revamp physician self-referral law grow louder

  July 18, 2018

• FDA reiterates concern about off-label use of bile-duct stents

  July 18, 2018

• Device industry lobbies FDA on combo product classification

  July 17, 2018

• J&J says medical device sales improve in second quarter

  July 17, 2018

• Abbott device to repair leaky heart valves approved

  July 16, 2018

• CMS targets data gaps in setting lab payments

  July 16, 2018

• Medtronic, UnitedHealthcare say value-based pact cut diabetes costs

  July 11, 2018

• Stryker names new president, tweaks leadership structure

  July 11, 2018

• Better cybersecurity safeguards urged for medical devices, EHRs

  July 10, 2018