Medical Devices: Page 103
-
Deep Dive
Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA
The pump has a higher rate of malfunction reports than rivals, according to an ECRI analysis of the FDA's MAUDE database. But it's hard to draw conclusions from a disparate system of safety reporting.
By Ricky Zipp • May 21, 2021 -
FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief
Jeff Shuren said Wednesday the agency might miss some Medical Device User Fee Amendments performance goals for PMA applications and 510(k) submissions.
By Greg Slabodkin • May 20, 2021 -
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 -
Sarah Silbiger via Getty Images
Guidance on safety testing, labeling of devices in MR environments finalized by FDA
The agency kept the structure of the draft but changed many details about how medical device developers should test their products.
By Nick Paul Taylor • May 20, 2021 -
Deep Dive
Virtual proctoring, training poised to be new normal in post-pandemic surgical interactions
Prior to the COVID-19 public health crisis, momentum to transition operating rooms into digitally connected learning environments was building. Social distancing mandates accelerated those efforts.
By Greg Slabodkin • May 19, 2021 -
OrbiMed, RA Capital top healthcare investors in Q1: CB Insights
OrbiMed topped the list in part because of the investment firm's activity in the medtech industry, where it put money into companies including AnchorDx, Noctrix Health and Adicon.
By Nick Paul Taylor • May 19, 2021 -
Bayer sees jump in Essure adverse event reports gleaned from social media
Most are based on online posts made from 2014 to 2016. The company, which pulled the birth control implant from the U.S. market in 2018, attributed the surge to fewer source documents giving it more time to complete each report.
By Nick Paul Taylor • May 18, 2021 -
Courtesy of Boston Scientific
Boston Scientific's Watchman shows low stroke rate in large registry at ACC
The fast-growing product performed well in an analysis of more than 36,000 people presented at the American College of Cardiology meeting, with low adverse event rates that surprised even the study's author.
By Susan Kelly • May 17, 2021 -
Sarah Silbiger via Getty Images
Paclitaxel, uncoated stents for PAD show similar mortality in real world study
The review of outcomes for Medicare beneficiaries contrasts a 2018 meta-analysis that identified a mortality signal for patients treated with drug-coated stents and balloons. Still, JAMA editors said mortality rates are troublingly high.
By Susan Kelly • May 17, 2021 -
Edwards tricuspid valve replacement cut leakage for 98% of participants in early trial results
A total of 56 patients were examined 30 days after a transcatheter tricuspid valve replacement procedure. Edwards now plans to start a pivotal trial, examining the procedure in 775 patients.
By Ricky Zipp • May 17, 2021 -
artJazz via Getty Images
Sponsored by Reed TechWhat is EUDAMED and Basic UDI-DI?
Learn more about Basic UDI-DI, unique to EUDAMED and on the radar of medical device manufacturers.
May 17, 2021 -
Alex Wong via Getty Images
CMS again delays breakthrough device payment rule in nod to skeptics
The agency acknowledged MCIT "could be problematic" in ensuring devices demonstrate value without additional risks for Medicare beneficiaries, depriving industry for now of a long-sought policy goal.
By Nick Paul Taylor • May 17, 2021 -
Sean Gallup via Getty Images
Magnets in Apple, Microsoft devices can interfere with implanted cardioverter defibrillators: study
The Swiss study assessed ICDs that were not implanted in patients, but researchers warned patients with implants to keep electronic devices at least one inch from their chest to prevent dangerous magnetic interactions.
By Greg Slabodkin • Updated March 1, 2022 -
Courtesy of Abbott
Abbott's Assurity, Endurity pacemakers recall dubbed Class I event by FDA
Attributed to moisture, the fault could prevent the devices from delivering pacing, causing an irregular heartbeat and shortness of breath. Abbott has received reports of 135 injuries but no deaths.
By Nick Paul Taylor • Updated May 19, 2021 -
Stefani Reynolds / Stringer via Getty Images
Lawmakers, industry urge CMS to push breakthrough payment rule as May 15 deadline looms
Amid speculation of another delay, Democrats in Congress wrote to acting CMS administrator Liz Richter voicing support for the Medicare Coverage for Innovative Technology rule.
By Nick Paul Taylor • May 13, 2021 -
Diabetes tech companies continue 2020's success with Q1 growth. Investors seem unimpressed.
Dexcom, Insulet and Tandem all grew revenue or sales in Q1, winning over Wall Street analysts but seemingly not investors. Meanwhile, the diabetes tech space grows with FDA's clearance of Bigfoot Biomedical's smart insulin pen.
By Ricky Zipp • May 12, 2021 -
Lintao Zhang / Staff via Getty Images
EU plans to impose additional regulations on medtech AI products, other 'high-risk' systems
The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a leading AI role globally.
By Nick Paul Taylor • May 12, 2021 -
Medtronic's HVAD controversy
Medtronic hit with another Class I recall regarding HeartWare HVAD system
The recall for instructions and patient manuals marks the system's third Class I recall in 2021 and fifth since 2018. One death and 64 injuries have been reported due to issues from the most recent recall.
By Ricky Zipp • May 12, 2021 -
OIG calls on EPA to review ethylene oxide cancer risks, possibly delaying new regulations until 2022
The Office of Inspector General wants the agency to conduct a fresh review of cancer risks from EtO emissions associated with medical device sterilization facilities. EPA's final commercial sterilizer rule had been slated for 2021.
By Susan Kelly • May 11, 2021 -
Alex Wong via Getty Images
FTC asks Allergan Aesthetics, Soliton for additional information on proposed $550M buyout
The regulator's second request for documentary material, which comes three months after the proposed deal was announced, is part of a deeper probe than its standard review of M&A.
By Nick Paul Taylor • Updated Aug. 11, 2021 -
Alex Wong via Getty Images
CMS implementation of breakthrough payment rule may be further delayed: Cowen
The agency will most likely push the start date back further to address the concerns of critics of the contentious Medicare Coverage of Innovative Technology initiative, an analyst contends.
By Nick Paul Taylor • May 10, 2021 -
Courtesy of Boston Scientific
TAVR readmission rates vary widely between hospitals for unknown reasons: study
Length of stay and discharge disposition only explained 15% of the inter-hospital variation. The study's authors have called for efforts to identify practices associated with low rates or readmission.
By Nick Paul Taylor • May 10, 2021 -
Robotic surgery outlook boosted by hospital spending pickup in Q1
Intuitive and Stryker said that system buys were stronger than expected in the first quarter. Zimmer also reported momentum for its Rosa system, while Globus had positive early feedback for its robotic spine technology.
By Susan Kelly • May 10, 2021 -
Morris MacMatzen / Stringer via Getty Images
With MDR nearing, EU updates guidance on transition to Eudamed database
The European Union no longer requires reporting obligations to be carried out as soon as the database becomes fully functional. The Medical Device Regulation takes effect May 26 and Eudamed will come online one year later.
By Nick Paul Taylor • May 7, 2021 -
Permission granted by iRhythm Technologies
iRhythm again meets with Medicare rate setter after cardiac monitoring pay cut by nearly $200
CEO Michael Coyle said during a Thursday earnings call the company has met with Novitas Solutions to discuss a different pricing methodology. Investors seemed encouraged as shares were up nearly 8% Friday morning.
By Ricky Zipp • May 7, 2021 -
FDA shares plan for restarting facility inspections, warns backlog will persist into 2022
In a projected base-case scenario, the agency expects to have cleared 26% of its backlog of medical product inspections by October. A total of 2,426 device and radiological health inspections remain for fiscal year 2021.
By Nick Paul Taylor • May 7, 2021
Previous
