FDA puts Class I label on Boston Scientific recall estimated to affect one-third of pacemaker line

The medtech giant took the action after discovering devices, once hailed as a growth driver, can incorrectly enter safety mode, putting patients at risk of serious injury.

By Nick Paul Taylor • Aug. 9, 2021

FTC warns it may challenge deals later as it's hit by 'tidal wave' of merger filings

"Companies that choose to proceed with transactions that have not been fully investigated are doing so at their own risk," the regulator said.

By Samantha Liss • Aug. 5, 2021

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Rival to Boston Scientific's Sentinel meets skeptics at FDA advisory panel

One expert said there's "compelling evidence that [Keystone Heart] not only didn't demonstrate efficacy, but there's a potential signal of harm."

By Nick Paul Taylor • Aug. 4, 2021

Philips ventilator recall labeled Class I by FDA, second in as many weeks

The recall was triggered by identification of a risk that ventilators will provide lower oxygen flow. The Class I event is separate from FDA's designation in July of a recall impacting millions of Philips sleep apnea and ventilator devices.

By Nick Paul Taylor • Aug. 4, 2021

Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic

Comments "overwhelmingly supported" the plan to use pre-pandemic data on the cost of inpatient stays to inform CMS' rates for fiscal 2022.

By Nick Paul Taylor • Aug. 3, 2021

FDA ups premarket application user fees by 2.5% for FY 2022

The base PMA fee will be $329,000, though the increase is far less than the 7% hike instituted last year.

By Greg Slabodkin • Aug. 2, 2021

Digital health, heart disease devices feature in latest FDA breakthrough designations

Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions.

By Nick Paul Taylor • Aug. 2, 2021

Patient deaths called 'injury,' 'other' in FDA medical device database: study

The analysis raises questions about the complex reporting system. FDA has reached out to the lead author for reports believed to be misclassified to perform its own evaluation.

By Ricky Zipp • Updated July 30, 2021

COVID-19 impact on US healthcare system will stretch for decades, Fitch says

Over the long term, hospitals will face increased pressure from tight labor and wage markets, especially for experienced staff, as well as rising pharmaceutical and supply chain costs, the ratings agency warned.

By Shannon Muchmore • July 29, 2021

Mayo Clinic named U.S. News top hospital for sixth straight year

The list, which already examines specialty areas like knee replacements, added seven new measures including care for spinal fusion and hip fracture.

By Shannon Muchmore • July 28, 2021

Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery

CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.

By Nick Paul Taylor • July 26, 2021

FDA labels Philips sleep apnea, ventilator recall Class I, ResMed eyes advantage

The agency notices come about one month after Philips announced the recall and began pulling machines from the market. Rival ResMed said there has been a "considerable increase in demand" for its products since the recall.

By Ricky Zipp • Updated July 23, 2021

Illumina-Grail merger subject of in-depth EU antitrust probe

European officials opened a three-month investigation of the deal, valued up to $8 billion, due to concerns it may reduce competition in the emerging liquid biopsy market. Illumina vowed to press on.

By Nick Paul Taylor • July 23, 2021

CDRH still digging out of backlog caused by COVID-19: Shuren

"We think it's more important to focus on the submissions we already have in house than to talk about products yet to come before us," the device center chief said. "Hopefully, sometime in 2022 we'll get back on track."

By Ricky Zipp • July 22, 2021

FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain

Acting FDA Commissioner Janet Woodcock wants Congress to give the agency "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."

By Nick Paul Taylor • July 22, 2021

J&J medical device sales return to pre-pandemic levels in Q2 as COVID-19 impact wanes

The company's return to growth, fueled by the recovery of elective volumes, could signal where procedure-dependent medtechs stand as the industry recovers from the effects of the coronavirus.

By Ricky Zipp • July 21, 2021

Radiation therapy 'under attack' from CMS cuts, professional body warns

Equipment manufacturers including Varian, ViewRay, Hitachi, Siemens and Elekta are among those that could also be affected by the reimbursement changes.

By Nick Paul Taylor • July 21, 2021

CMS pitches stiffening price transparency fines, halting end of inpatient-only list

The proposed rule moves hundreds of procedures back to hospitals and reverses a Trump-era regulation that attempted to phase out the inpatient-only list. An ASC representative called the regulatory back-and-forth "jarring."

By Shannon Muchmore • July 20, 2021

Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target

The agency's OK for the spinal cord stimulation device potentially opens a market worth billions of dollars. For now, though, preliminary quarterly revenue came in below its prior forecast.

By Nick Paul Taylor • July 20, 2021

NuVasive's scoliosis system gets reinstated CE mark, new instructions for use

FDA said in a Friday safety communication that NuVasive has also lifted a shipping hold for MAGEC systems outside of the U.S. The company lifted a U.S. shipping hold in July.

By Nick Paul Taylor , Ricky Zipp • Updated Dec. 13, 2021

FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk

The agency, which announced the revocation on Thursday, originally granted an emergency use authorization to Curative's test in April 2020. By January, FDA had concerns about false results potentially linked to sample collection.

By Nick Paul Taylor • July 16, 2021

Dexcom wins FDA nod for real-time APIs, allowing third-party developers access to CGM data

Teladoc Health's Livongo and smartwatch maker Garmin are in the testing and development phase, Dexcom said. The clearance comes as FDA is working to address the devices backlog created by the pandemic.

By Ricky Zipp • July 16, 2021

Kiwa Cermet Italia becomes 21st notified body under MDR amid capacity concerns

It is the first new NB since May's date of application and the fourth organization to be designated this year. But, MedTech Europe has warned about limited certification capacity as thousands of certificates are set to expire before 2024.

By Nick Paul Taylor • July 15, 2021

Transmedics wins premarket approval for OCS liver system, adding to recent FDA nods

The company was granted premarket approval for the OCS heart system and 510(k) clearance for the OCS lung solution. Transmedics' stock price was up over 6% following the Wednesday announcement.

By Nick Paul Taylor • Updated Sept. 29, 2021

CMS proposes extension of Medicare telehealth coverage

Provider groups are not happy with the payment adjustment in the rule — a 3.75% reduction to the conversion factor due to budget neutrality requirements — and will likely seek congressional intervention.

By Shannon Muchmore • July 14, 2021