FDA: Page 44
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Permission granted by Roche
Roche's refillable eye implant becomes Eylea's latest threat
The FDA has approved Susvimo, a device that continuously administers a version of Roche's Lucentis over several months. It could challenge Regeneron's top-selling drug.
By Ben Fidler • Oct. 25, 2021 -
EU task force calls for MDR legacy device surveillance requirements
The Medical Device Coordination Group said legacy devices are subject to rules on post-market surveillance, market surveillance and vigilance. Manufacturers need to create and maintain periodic safety update reports.
By Nick Paul Taylor • Oct. 25, 2021 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Getty / Edited by Healthcare Dive
Tenet sees widespread volume recovery, again raises forecast
Despite the operating challenges poised by COVID-19 in the third quarter, the for-profit health system was able to manage through the headwinds, executives said Thursday during a call with investors.
By Samantha Liss • Oct. 22, 2021 -
Permission granted by Medtronic, Megan Rosengarten
Q&AMedtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges
Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.
By Ricky Zipp • Oct. 20, 2021 -
Alex Wong via Getty Images
In last ditch plea to save MCIT, medtech groups suggest fixes to CMS
AdvaMed and MDMA responded to a call for feedback on the planned repeal of the Medicare Coverage of Innovative Technology pathway by proposing tweaks and new ideas to salvage it.
By Nick Paul Taylor • Oct. 20, 2021 -
Sarah Silbiger via Getty Images
Over-the-counter hearing aids proposed by FDA
A Cowen analyst said the policy change would allow consumer electronics manufacturers to get into the lucrative hearing aid market that has been dominated by ReSound, Sonova and William Demant.
By Greg Slabodkin • Oct. 19, 2021 -
Courtesy of Abbott
Abbott software causing COVID-19 test false positives, starts Class I recall fix
FDA said use of the tests before the problem is corrected may cause serious adverse health consequences or death, alerting laboratories to treat the results as presumptive and that they may need to be confirmed with another test.
By Nick Paul Taylor • Oct. 19, 2021 -
Philips sees sleep business recovering from recall in H2 2022, analysts doubtful
William Blair analysts warn that limited provider support during the medtech's recall is hurting brand credibility and impacting Philips' ability to regain market share, while positioning ResMed as the beneficiary of "durable" share loss.
By Greg Slabodkin • Updated Oct. 22, 2021 -
Deep Dive
Anatomy of a medical device recall: How defective products can slip through an outdated system
"It truly is like we are operating in about the 1950s," one consultant noted of the process. The FDA has held two meetings in the past year to mull improvements.
By Ricky Zipp • Oct. 18, 2021 -
Getty Images
Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA
The agency is mulling the types of information medtechs might include in labeling for such devices to support transparency. A Philips rep cautioned about the pitfalls of "information overload."
By Greg Slabodkin • Oct. 15, 2021 -
Win McNamee via Getty Images
Biden circling former FDA chief Califf to again lead agency: report
The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.
By Ricky Zipp • Oct. 15, 2021 -
The European Commission has caved to pressure on extending IVDR. Now what?
The EC's proposal creates a new set of timelines for the industry to meet and questions to consider — assuming it passes into law without further changes.
By Nick Paul Taylor • Oct. 15, 2021 -
Boston Scientific, Sterigenics potential targets of EPA ethylene oxide reporting requirements
The agency has written to the operators of 31 medical device sterilization facilities, outlining its plans and requesting information to inform its final decision.
By Nick Paul Taylor • Oct. 14, 2021 -
Sarah Silbiger via Getty Images
Withings gets FDA nod for AFib-detecting wearable, taking on Apple
The device, which is capable of detecting atrial fibrillation, combines an analog watch face with health features found in digital smartwatches. The French company joins Apple, Fitbit and Samsung in a crowded market.
By Nick Paul Taylor • Oct. 13, 2021 -
Getty Images
FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response
The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.
By Nick Paul Taylor • Oct. 12, 2021 -
European Commission adds 2 modules to delayed Eudamed database, with no follow-on timeline
Sections on UDI/device registration, and Certificates and Notified Bodies are now available for voluntary use but some features are missing.
By Nick Paul Taylor • Oct. 12, 2021 -
Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff
The system will hit the European market after the medtech giant unveiled it in 2019 and delayed the timeline amid the pandemic. Medtronic will take on market leader Intuitive Surgical and an upcoming product from J&J.
By Ricky Zipp • Oct. 11, 2021 -
Getty Images
FDA beefs up surgical stapler oversight after injuries, death reports
While medtechs like J&J and Medtronic backed the broad change, the final rule held firm on several contentious elements. The agency also updated labeling guidance of both staplers and staples due to patient safety risks.
By Nick Paul Taylor • Oct. 8, 2021 -
Michael Nagle via Getty Images
Deep DiveHow Morgan Health hopes to finally move the needle on employer health costs: 5 insights from a chat with the venture's CEO
Morgan Health learned a lot from Haven, but is a different beast with better knowledge of the buy-in needed to disrupt the health benefits space, CEO Dan Mendelson told Healthcare Dive.
By Rebecca Pifer • Oct. 8, 2021 -
Sean Gallup via Getty Images
Deep DiveWill a software bill of materials help or hurt medical device cybersecurity?
President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.
By Greg Slabodkin • Oct. 7, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Labcorp, PerkinElmer latest to target COVID-flu combo test market
FDA gave a nod to Labcorp's diagnostic, which uses a Roche test for SARS-CoV-2, influenza A and influenza B. PerkinElmer's assay also got emergency authorization for those three viruses as well as respiratory syncytial virus.
By Greg Slabodkin • Oct. 7, 2021 -
Courtesy of Ellume Health
FDA labels Ellume's recent COVID-19 Home Test recall Class I event
The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.
By Nick Paul Taylor • Updated Nov. 10, 2021 -
EU shares guide to MDR's 22 rules for classifying medical devices
If a manufacturer and notified body dispute a classification, the case may be referred to the competent authority in the country where the company has its registered place of business.
By Nick Paul Taylor • Oct. 6, 2021 -
Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks
The recalls have hit the medtech giant at a time when competitors Insulet and Tandem are ramping up in the insulin pump market and amid flagging sales in its diabetes unit.
By Susan Kelly • Oct. 5, 2021 -
Sarah Silbiger via Getty Images
FDA resists industry push to nix De Novo inspections in final rule
"The most controversial aspect was FDA's provision for ... an FDA inspection for what is tantamount to a 510(k)," noted Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green.
By Nick Paul Taylor • Oct. 5, 2021
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