FDA: Page 48
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Joe Raedle via Getty Images
Rising hospital ransomware attacks could endanger patients, hit bottom lines hard, Moody's says
Systems have been rendered more vulnerable due to COVID-19 as more non-clinical employees work from home. The warning echos comments made recently by the FDA's cyber chief for medical devices.
By Ron Shinkman • May 27, 2021 -
Sarah Silbiger via Getty Images
FDA draft guidances lay out postmarket medical device data requirements
Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs.
By Nick Paul Taylor • May 27, 2021 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Courtesy of Abbott, PRNewswire
HHS commits $4.8B to COVID-19 testing for the uninsured
The American Clinical Laboratory Association, with members including LabCorp and Quest Diagnostics, had urged the Biden administration in February to make more money available.
By Susan Kelly • May 26, 2021 -
MDR challenges remain as regulation goes into effect: MedTech Europe
The European trade group contends that while the Medical Device Regulation's May 26 effective date marks a significant milestone, hurdles limit industry’s ability to "seamlessly supply certified devices under the new rules."
By Greg Slabodkin • May 26, 2021 -
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 • 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 -
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 -
Courtesy of Quest Diagnostics
Labs urge HHS to back new regulatory regime for diagnostic tests
The trade group for Quest, LabCorp and others wants the Biden administration to back legislation to create a framework for laboratory developed tests separate from medical devices.
By Susan Kelly • May 24, 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 -
Danielle Ternes
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 -
Sean Gallup via Getty Images
FDA opposes COVID-19 antibody testing to assess post-vaccination immunity
The warning comes as some medtechs bet on the tests. Beckman Coulter unveiled a fully quantitative one just as the agency issued the safety notice.
By Nick Paul Taylor • May 20, 2021 -
Courtesy of Exact Sciences
US panel trims colorectal cancer screening age, opens door to annual Cologuard use
William Blair said the recommendations are a positive for Exact Sciences, which has framed the guidance as a chance to drive growth by targeting 19 million people in the screening cohort.
By Nick Paul Taylor • May 19, 2021 -
Jacob Bell
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 -
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 -
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 -
Alex Wong via Getty Images
Providers supportive of push to overhaul HIPAA, but air serious concerns about data privacy, timing
"We urge OCR to reconsider implementing a massive change to patient privacy laws in the midst of this transition," AMA commented on the Trump-era rule.
By Rebecca Pifer • May 11, 2021
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