FDA: Page 45
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CMS finalizes plans for pay cuts for radiation oncology, other specialists
Device makers could feel the pinch in cuts to services that use pricey equipment for vascular surgery, interventional radiology and diagnostic testing, which AdvaMed contends will decrease patient access to care.
By Shannon Muchmore • Nov. 3, 2021 -
CMS reinstates Medicare's inpatient-only list in final rule, reversing Trump-era nix
Medtronic, Johnson & Johnson, Stryker and Zimmer Biomet overwhelmingly supported restoring the IPO list in public comments to the July proposed rule. The backing comes as the industry also embraces outpatient care.
By Ricky Zipp • Nov. 3, 2021 -
Explore the Trendlineâž”
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 -
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Outset nabs first CMS home dialysis add-on payment, setting up fight with Fresenius
The company, whose application was rejected last year, persuaded the Medicare agency its portable dialysis machine is a "substantial clinical improvement" over the incumbent home-use hemodialysis product.
By Nick Paul Taylor • Nov. 3, 2021 -
Sarah Silbiger via Getty Images
Safety of Endologix endovascular graft device center of FDA panel review
The medtech competes in a space targeted by companies including Cook Medical and Medtronic. Agency advisers will discuss the broader endovascular graft market Wednesday.
By Nick Paul Taylor • Nov. 2, 2021 -
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Siemens' Varian leads latest FDA breakthrough device designations
Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.
By Nick Paul Taylor • Nov. 1, 2021 -
Sarah Silbiger via Getty Images
FDA, global peers create guiding principles for AI/ML medical devices
The U.S., U.K. and Canada are seeking international harmonization as part of a broader discussion on the development of safe, effective devices that use artificial intelligence and machine learning.
By Nick Paul Taylor • Oct. 29, 2021 -
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What does J&J's Ottava delay mean for Intuitive and Medtronic? It's complicated.
The setback doesn't remove hurdles the rivals face playing catch-up to market leader Intuitive's da Vinci, which has a two-decade head start.
By Ricky Zipp • Oct. 28, 2021 -
FDA restricts breast implant sales, cites Allergan and J&J for inadequate postapproval progress
The agency also made official a boxed warning, after an advisory panel heard from dozens of patients with a cancer associated with breast implants and symptoms of a related illness.
By Nick Paul Taylor • Oct. 28, 2021 -
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FDA's 2022 A-list guidance plan hits on software, post-pandemic future
The agency's priorities include a much-anticipated final guidance on clinical decision support software — more than five years in the making — meant to clarify when CDS meets the definition of a medical device.
By Nick Paul Taylor • Oct. 27, 2021 -
Notified bodies join chorus of criticism of proposed European AI regs
Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.
By Nick Paul Taylor • Oct. 26, 2021 -
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 -
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 -
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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 -
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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 -
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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
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