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CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways
The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.
By Nick Paul Taylor • Updated Nov. 12, 2021 -
Image courtesy of Vicarious Surgical
Robotics startup Vicarious files pre-submission with FDA, fresh from $220M SPAC raise
The filing is part of a push to establish the robotic surgical system in a space fought over by Intuitive Surgical, Johnson & Johnson and Medtronic.
By Nick Paul Taylor • Nov. 9, 2021 -
Explore the Trendline➔
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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 -
Permission granted by iRhythm Technologies
iRhythm's COVID-19 pressures add to Medicare pricing saga
New CEO Quentin Blackford told investors "significant" customer staffing issues are likely to drag on through Q4, limiting the company's capacity and forcing it to lower 2021 guidance.
By Ricky Zipp • Nov. 5, 2021 -
Sarah Silbiger via Getty Images
FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy
The proposal applies to all types of premarket submissions and includes both software in and Software as a Medical Device.
By Nick Paul Taylor • Nov. 4, 2021 -
Adeline Kon/Healthcare Dive/MedTech Dive
Deep DiveWhy are women more likely to use telehealth?
As Washington mulls over telehealth regulations post-COVID-19, it's important not to roll back access in a way that could disproportionately affect women, experts say.
By Rebecca Pifer • Nov. 3, 2021 -
Alex Wong via Getty Images
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 -
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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 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
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 -
Sarah Silbiger via 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
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