FDA: Page 50
-
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 -
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
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 -
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 -
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 -
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
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 -
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 -
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 -
Sarah Silbiger via Getty Images
AI, digital health feature in latest batch of FDA breakthrough device designations
The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.
By Nick Paul Taylor • May 5, 2021 -
Q&A
Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions
While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.
By Ricky Zipp • May 3, 2021 -
CMS finalizes joint replacement pricing extension with input from medtech industry
Cowen analysts say the agency's initiative could evolve in ways that put pressure on the prices of orthopaedic devices. However, they contend companies can mitigate that threat by selling more products to customers.
By Nick Paul Taylor • April 30, 2021
Previous
