UK health authority 'proactively' monitoring breast implant illness reports

In guidance for patients and clinicians on symptoms "sometimes referred to as Breast Implant Illness," the Medicines and Healthcare products Regulatory Agency stopped short of linking the devices to reported illnesses.

By Susan Kelly • Jan. 21, 2020

5 medtech trends to track in 2020

With the medical device tax in the rearview mirror, industry worries include the uncertain future for product sterilization, the "valley of death" between product authorization and reimbursement, and enforcement of new EU regulations.

By Maria Rachal , David Lim • Jan. 17, 2020

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Virtual, augmented reality in medicine pique FDA's interest

The agency is hosting a workshop Wednesday with representatives from Microsoft, Facebook, Philips and other industry players in hopes of identifying roadblocks to developing more uses of extended reality for medical purposes.

By Nick Paul Taylor • Jan. 17, 2020

Edwards' US patent challenge to Abbott MitraClip IP denied

In a decision Thursday, the Patent Trial and Appeal Board thwarted Edwards Lifesciences' petition arguing certain Abbott mitral valve repair claims are unpatentable, the latest in a transatlantic battle between the companies.

By Nick Paul Taylor • Jan. 17, 2020

Dexcom talks up Type 2 market, Medtronic says it has 'work to do' in diabetes at JPM

The San Francisco conference featured presentations from most major insulin delivery and glucose monitoring players, preceded by a handful of new funding announcements including a $93 million Series C for Virta Health.

By Maria Rachal • Jan. 16, 2020

Study of Abbott's HeartMate 3 points to single treatment indication for LVADs

A study in JAMA Cardiology suggests it's unnecessary to group heart failure patients by transplant eligibility, which one cardiologist said could allow physicians to sidestep difficult upfront decisions about transplants and pumps.

By Nick Paul Taylor • Jan. 16, 2020

ResMed pays more than $37.5M to settle false claims allegations

The settlement covers accusations that the sleep apnea and respiratory conditions medical equipment maker provided free and below-cost products and services to spur patient referrals.

By Nick Paul Taylor • Updated Jan. 20, 2020

REVA files for bankruptcy after bioresorbable scaffold flops

The company pinned its failure to grow sales on the European Society of Cardiology's preference for conventional drug-eluting stents.

By Nick Paul Taylor • Jan. 16, 2020

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

CEO Mike Mahoney, speaking at the J.P. Morgan Healthcare Conference, partly blamed underperformance on a December slowdown in the U.S. defibrillator business, but said the company is still sorting out reasons for the softness.

By Susan Kelly • Jan. 15, 2020

Health IT to lead 2020 deals, KPMG predicts

The repeal of the medical device tax could boost investor interest in hot areas like non-invasive diagnostics, robotic surgery and AI-enabled devices, although health IT, pharma and biotech appear to be drawing more excitement.

By Linda Wilson • Jan. 15, 2020

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.

By Nick Paul Taylor • Jan. 15, 2020

Medtronic at JPM: More tuck-ins under Martha and key trial results ahead

Incoming CEO Geoff Martha also said management agrees "certain pockets of the company probably have a little bit too much bureaucracy."

By Maria Rachal • Jan. 14, 2020

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

Robot-assisted procedures jumped from accounting for 1.8% of all general surgeries in 2012 to 15.1% in 2018. Closer monitoring is needed to ensure clinical benefits and safety are prioritized, researchers said.

By Susan Kelly • Jan. 14, 2020

RTI Surgical inks $490M deal to sell OEM unit to private equity

The divestiture will turn Michigan-based RTI into a pure play spine company with up to $200 million in cash, as private equity groups show growing interest in the medical technology sector.

By Nick Paul Taylor • Jan. 14, 2020

Nevro, NuVasive, Integra, others preview earnings at JPM

Wednesday's lineup of medtech presenters includes Exact Sciences, Intersect ENT, ICU Medical and handheld ultrasound device maker Butterfly.

By Maria Rachal • Updated Jan. 15, 2020

FDA guidance on catheters zeros in on testing, coatings

The agency wants to see consistency across 510(k) submissions for various types of Class II percutaneous transluminal angioplasty balloon catheters.

By Susan Kelly • Jan. 13, 2020

Enrollment has ended in Essure postmarket study, FDA says

Bayer discontinued sales of the permanent birth control implant more than a year ago but continues to study its safety profile, as directed by the agency.

By Susan Kelly • Jan. 13, 2020

FDA OKs Abbott clinical trial of MitraClip in moderate risk patients

The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery. 

By David Lim • Jan. 13, 2020

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.

By David Lim • Jan. 10, 2020

Intuitive closes 2019 by topping Q4 expectations

Intuitive's 19% procedure growth helped it increase sales by 22%, according to preliminary results. But Medtronic, J&J and CMR Surgical are among the competitors that will press for share in the next few years.

By Nick Paul Taylor • Jan. 10, 2020

JenaValve TAVR tech amid wave to get breakthrough device status from FDA

Other devices recently designated include 3Derm Systems' AI to detect skin cancers, KDx Diagnostics' urine-based bladder cancer test, and Reflow Medical's retrievable stent for use in below-the-knee peripheral artery disease.

By Nick Paul Taylor • Jan. 10, 2020

Medtronic buys new spinal cord tech to boost pain therapies unit

Amid a broader slowdown in the spinal cord stimulation market, Medtronic is acquiring technology from Stimgenics that offers a new way of programming its Intellis implant.

By Maria Rachal • Jan. 9, 2020

Study links paclitaxel devices to better survival in PAD, muddying debate

New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.

By David Lim • Jan. 9, 2020

MedTech Europe pushes urgent action to keep devices on sale after MDR

The trade group wants the EU to fix perceived problems with the grace period to allow devices to stay on the market and be reviewed by an MDR-designated notified body.

By Nick Paul Taylor • Jan. 9, 2020

Abbott sets CFO transition in motion

The company plans to install a new chief financial officer a month before incoming CEO Robert Ford takes the helm.

By Maria Rachal • Jan. 8, 2020