FDA to exempt handful of devices from 510(k) requirements

The latest deregulatory step does not exempt the products from other mandates such as registration and listing, labeling, good manufacturing practices and medical device reporting requirements.

By David Lim • Feb. 8, 2019

India seeks to lure medtech to growing market

Only about 400 of the roughly 5,000 medical devices marketed in India are currently regulated. 

By Meg Bryant • Updated Feb. 12, 2019

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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

Boston Scientific, Coloplast transvaginal meshes in spotlight at FDA panel

Expert advisors are meeting Tuesday to weigh the risks and benefits of the controversial devices. The agency moved them into the high-risk Class III category in 2016 after thousands of adverse events were reported.

By Maria Rachal • Updated Feb. 11, 2019

Bigfoot adds Owen Mumford needles to diabetes subscription service

The agreement sets Bigfoot up to provide users of its automated insulin delivery devices with pen needles.

By Nick Paul Taylor • Feb. 8, 2019

Smith & Nephew has Q4 sales miss as headwinds persist

Falling sales of arthroscopic enabling technologies led the London-based company to fail to meet analyst revenue expectations for the quarter.

By Nick Paul Taylor • Feb. 7, 2019

Medtronic nabs expanded indication for Pipeline Flex embolization device

The device, first approved for endovascular treatment of adults with certain large or giant wide-necked intracranial aneurysms, is now also indicated for patients with certain small or medium aneurysms.

By David Lim • Feb. 7, 2019

Breast implant-associated lymphoma tied to at least nine US deaths, FDA says

The agency reported at least 457 unique cases of a form of non-Hodgkin lymphoma potentially linked to the device. The updated data comes weeks before a March advisory panel meets to examine known breast implant risks.

By Maria Rachal • Feb. 7, 2019

Teleflex granted FDA approval for vascular closure device

The product is designed to seal femoral punctures following vascular access medical procedures.

By Susan Kelly • Feb. 6, 2019

Boston Scientific targets structural heart, international market growth in 2019

A near-constant stream of acquisitions defined the device giant's 2018. Now, it's looking ahead to product launches in the U.S., Europe and Japan.

By Maria Rachal • Feb. 6, 2019

FDA draft lays out submission paths for combo products

Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.

By David Lim • Feb. 6, 2019

BD results largely expected, beats on revenue

One year after closing the acquisition of C.R. Bard, the company said it is on track to achieve expected cost and revenue goals.

By Susan Kelly • Feb. 5, 2019

CMS eases study parameters in depression device coverage decision

LivaNova seeks to enroll clinical trial patients beginning in the third quarter of 2019. Those patients will only need to demonstrate response rather than remission, per CMS updates to the finalized decision memo.

By Maria Rachal • Updated Feb. 19, 2019

FDA warns cardiologists of high mortality in Abiomed post-approval study

The 17% survival rate in the post-approval study of its Impella temporary right heart pump system prompted FDA to write to healthcare professionals and wiped 6% of Abiomed's stock.

By Nick Paul Taylor • Feb. 5, 2019

Cook Medical aortic dissection device gets FDA approval

The device is designed to repair Type B dissections of the descending thoracic aorta in a minimally invasive procedure.

By Susan Kelly • Feb. 5, 2019

FDA redefines 'least burdensome' as critics fear chilling effect on reviewers

A watchdog argues the guidance is the agency's latest step to speed device approvals at the expense of robust patient protection.

By David Lim • Feb. 5, 2019

FDA announces warfarin test strips, IV fluid transfer systems recalls

The agency identified separate Class I recalls addressing malfunctions in certain Roche Diagnostics test strips and Vial2Bag fluid transfer systems made by West Pharmaceutical Services.

By Susan Kelly • Feb. 4, 2019

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

The Lithuania-based startup is betting the system can help radiologists increase productivity, detect hard-to-catch pathologies, decrease error rates and serve as a second opinion.

By Susan Kelly • Feb. 4, 2019

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

The device giant obtained the product as part of its $1.28 billion acquisition of Physio-Control in 2016.

By Susan Kelly • Feb. 4, 2019

Zimmer Biomet narrowly beats Q4 expectations, looks to Rosa knee soft launch

RBC Capital Markets analysts predicted the company's second half of 2019 is primed for faster growth once Rosa and other new knee product launches kick in.

By David Lim • Feb. 1, 2019

Edwards' sales on track, but outlook cautious

The device maker is rolling out new transcatheter aortic valve replacement products at a measured pace to give surgeons time to become familiar with the technology.

By Susan Kelly • Feb. 1, 2019

Abiomed posts 30% growth on rising heart pump demand

Analysts think the medtech can sustain its rapid growth because of its potential to enter new indications and geographies.

By Nick Paul Taylor • Feb. 1, 2019

Digital health must catch up to years of hype in 2019, HIMSS says

The Healthcare Information and Management Systems Society also forecasts the sector will face rising consumer pressures and see increased use of social determinants of health data.

By Rebecca Pifer Parduhn • Jan. 31, 2019

FDA sets neurology, microbiology device panel meetings for March

Advisory committees will discuss a De Novo application for an Alzheimer's therapy and new approaches to evaluate HPV screening devices.

By Maria Rachal • Jan. 31, 2019

HHS to seek changes to anti-kickback laws by year end

The bid to overhaul the Stark Law and Anti-Kickback Statute comes as lawmakers propose legislation to facilitate value-based arrangements connecting the price of a medical device or drug to clinical effectiveness.

By David Lim • Jan. 31, 2019

Breast health and diagnostics drive Hologic to beat-and-raise quarter

Double-digit growth by Hologic's core businesses offset ongoing underperformance by its Cynosure medical aesthetics unit.

By Nick Paul Taylor • Jan. 31, 2019