Medical Devices: Page 167
-
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 -
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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
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 -
Deep Dive
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 -
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 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 -
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 -
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 -
Jacob Bell/MedTech Dive
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 -
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 • 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 -
Baxter beats estimates despite ongoing medication delivery woes
To drive long-term growth, Baxter is "very aggressively" looking for takeover targets, CEO José Almeida said on an earnings call.
By Nick Paul Taylor • Jan. 31, 2019 -
Cybersecurity device plan seeks alignment of industry, regulators
A team led by representatives from BD, Mayo Clinic and FDA released a guide on managing the security of medical devices in clinical practice.
By Susan Kelly • Jan. 30, 2019 -
Stryker impresses in Q4, sets bold forecasts
The Kalamazoo, Michigan-based medical device maker forecast organic sales growth in the range of 6.5% to 7.5% in 2019 that represents its strongest outlook in a decade.
By Susan Kelly • Jan. 30, 2019 -
Tumbling breast implant sales drag on Allergan's Q4 results
The loss of a CE mark contributed to a 74% drop in European sales of the devices.
By Nick Paul Taylor • Jan. 30, 2019 -
Gottlieb, Shuren tout 2018 as 'record' year for novel devices
The FDA officials also cited progress with real world evidence, pondered expanding authorities to revamp the 510(k) system and floated creating a fast-track pathway for products addressing non-life-threatening diseases.
By Maria Rachal • Jan. 29, 2019 -
J&J data suggests its stapler reduces more lung surgery air leaks than competitor
The company pointed to research indicating use of its Ethicon surgical stapler in a lung cancer procedure led to less than half the rate of air leak complications than Medtronic's design did.
By Susan Kelly • Jan. 29, 2019
Previous
