Medical Devices: Page 116
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Senate confirms Chiquita Brooks-LaSure as head of CMS
AdvaMed and MDMA both called out the Medicare Coverage of Innovative Technology rule, now delayed, as a priority for the new administrator. President Joe Biden has yet to name an FDA chief.
By Rebecca Pifer Parduhn • May 25, 2021 -
Leon Neal via Getty Images
Ransomware, other cyber threats mount as medtech industry tries to adapt
"Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless.
By Greg Slabodkin • May 25, 2021 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Sarah Silbiger via Getty Images
FDA clears 2 endoscopes that avoid reprocessing
The agency, which has urged a shift to endoscopes with single-use parts or that are fully disposable, gave the OK to UroViu to market a single-use cytoscope and to China's EndoFresh for a disposable digestive endoscopy system.
By Susan Kelly • May 25, 2021 -
MDR is live. Here are 5 things to know on where the rule stands.
The device industry has resolved some near term pressures as the EU's delayed landmark regulation comes into effect, but challenges related to IVDR, Brexit and more remain.
By Nick Paul Taylor • May 25, 2021 -
Sarah Silbiger via Getty Images
Boston Scientific recalls venous stents because of migration risk
The medtech giant is recalling all Vici SDS and Vici RDS stent systems distributed over a 30-month period after receiving 17 complaints. The FDA categorized it as a Class I recall, its most serious designation.
By Nick Paul Taylor • May 24, 2021 -
Retrieved from Official White House Photo by Adam Schultz.
Biden orders Software Bill of Materials to boost cybersecurity. AdvaMed wants uniform standards.
An executive order calls for an electronically readable way to provide an inventory of third-party components in devices. The medtech lobby backs the idea but says standardization is critical.
By Greg Slabodkin • May 21, 2021 -
Sarah Silbiger via Getty Images
FDA seeks feedback on device ingredient labeling requirements
The agency held a public meeting late in 2019 debating adding more specific information on materials used in devices with long-term exposure such as breast implants and metal-on-metal hips.
By Nick Paul Taylor • May 21, 2021 -
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 -
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 -
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
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