Medical Devices: Page 136
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House bill would speed CMS coverage for breakthrough medtech
The bipartisan legislation, reintroduced on Friday, promises faster access to new medical technologies by requiring Medicare to cover devices approved through FDA's breakthrough pathway during a three-year transitional period.
By Susan Kelly • Dec. 9, 2019 -
FDA proposes alternative 510(k) criteria for MRI coils
The draft guidance would permit manufacturers to use a set of performance criteria to demonstrate substantial equivalence, instead of a direct comparison to a predicate device.
By Susan Kelly • Dec. 9, 2019 -
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 -
Impeachment clouds year-end medical device tax repeal, industry priorities
AdvaMed argues the primary obstacle to repealing the tax is not the revenue the government would no longer collect, but a crowded year-end legislative agenda and impeachment proceedings against President Donald Trump.
By David Lim • Dec. 9, 2019 -
Dive Awards
Disruption of the Year: EU MDR notified bodies shortage
The new European Union Medical Device Regulation requires more devices to undergo notified body review than ever before. But there are worries there aren't enough notified bodies to handle the workload.
By Dana Elfin • Dec. 9, 2019 -
Kendall Davis/MedTech Dive
Dive Awards
Rivalry of the Year: Abbott and Dexcom's race to dominate CGM
As tech-led diabetes management becomes more mainstream, the "lead horses" in continuous glucose monitor manufacturing have committed to multiplying production capacity and are eyeing expansion into new populations.
By Maria Rachal • Dec. 9, 2019 -
Dive Awards
Executive of the Year: Kevin Lobo, Stryker
Stryker's year was shaped by two of the biggest fruits of the newly minted AdvaMed chairman's dealmaking: expansion of the Mako robot and the addition of Wright Medical.
By Maria Rachal • Dec. 9, 2019 -
Dive Awards
Company of the Year: Edwards Lifesciences
With a laser focus on structural heart care, the company's transcatheter aortic valve replacement technology proved superior and gained approval among patients once considered better candidates for open heart surgery, lifting its stock more than 60%.
By Susan Kelly • Dec. 9, 2019 -
Kendall Davis/MedTech Dive
Dive Awards
The MedTech Dive Awards of 2019
From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.
Dec. 9, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Dive Awards
Regulatory Development of the Year: 510(k) changes inch along
New efforts by FDA to build out the program come years after the Institute of Medicine recommended scrapping it. More than 80% of devices are cleared through the pathway, so small changes can be meaningful to product safety.
By David Lim • Dec. 9, 2019 -
EPA wants more data from ethylene oxide sterilizers, strikes device-friendly tone
Administrator Andrew Wheeler said "medical device sterilization is vital to protecting public health" on release of a notice ahead of rulemaking that could impact sterilizers reliant on the carcinogenic gas.
By David Lim • Dec. 6, 2019 -
Analysts cool expectations for Edwards' mitral performance
Edwards execs told investors Thursday sales in the transcatheter mitral and tricuspid valve business should roughly double in 2020, but that's after a year when the unit's sales will likely fall short of initial targets.
By Maria Rachal • Dec. 6, 2019 -
Establishment Labs' breast implant opportunity to triple: Jefferies
The analysts predict entering China and the U.S. will open up markets worth close to $1 billion.
By Nick Paul Taylor • Dec. 6, 2019 -
US healthcare spending growth rebounded last year, influenced by insurance tax
Durable medical equipment annual growth jumped from 2.9% in 2017 to 4.7% in 2018.
By Shannon Muchmore • Dec. 5, 2019 -
Edwards projects up to $5B in 2020 sales
Across the aortic, mitral and tricuspid valve therapy markets Edwards Lifesciences targets, the company now expects worldwide opportunities to exceed $10 billion by 2024, per fresh estimates given to investors Thursday.
By Maria Rachal • Dec. 5, 2019 -
FDA grades new Medtronic SynchroMed II recall as Class I event
The voluntary move is the latest in a series of safety actions involving the implantable drug infusion pump, which was the focus of a 2015 consent decree between the company and the government.
By Nick Paul Taylor • Updated Dec. 10, 2019 -
Jacob Bell/MedTech Dive
Vicarious' surgical robot gets FDA breakthrough status
The company also announced Scott Huennekens, former CEO of Google and Johnson & Johnson's robotic surgery joint venture, joined its board of directors.
By Nick Paul Taylor • Dec. 5, 2019 -
Boston Scientific afib device effective in reducing stroke
Authors in the Journal of the American College of Cardiology said the rate of hemorrhagic stroke observed in left atrial appendage closure device registries is the lowest identified in the nonvalvular atrial fibrillation population.
By Nick Paul Taylor • Dec. 5, 2019 -
EU Parliament panel adopts MDR delay for some Class I devices, full nod likely
One committee member called out the unusual nature of making late-in-the-game substantive regulatory changes through the corrigendum, a procedure typically meant for correcting technicalities and inconsistencies.
By Dana Elfin • Dec. 4, 2019 -
FDA commissioner nominee backs 'proactive, not passive' approach to device safety
While Stephen Hahn shed more light on his thoughts on certain medical device topics, he declined to say FDA scientific judgments of medical devices should be held to the same regulatory standards as drugs in response to a question.
By David Lim • Dec. 4, 2019 -
Contract sterilizer of devices draws FDA warning over validation issues
American Contract Systems received multiple complaints about the presence of foreign matter in sealed sterilization bags, the agency said.
By Nick Paul Taylor • Dec. 4, 2019 -
Medtronic and Elekta form radiation therapy pacts with ViewRay
ViewRay's plans to raise $75 million should help reduce concerns surrounding the company's liquidity, analysts at Jefferies said.
By Nick Paul Taylor • Dec. 3, 2019 -
FDA seeks public input on pediatric device applications including ways to minimize burden
The agency said it expects to receive about 47 original premarket approval, product development protocol or humanitarian device exemption submissions each year. About 11 submissions will lack required pediatric use information.
By Susan Kelly • Dec. 2, 2019 -
Courtesy of Sanofi
Baxter closes $350M acquisition of Sanofi's Seprafilm adhesion barrier
The company said it will immediately begin integrating the product, meant to reduce adhesion barriers in patients having abdominal or pelvic laparotomy procedures, into its advanced surgery business.
By Maria Rachal • Updated Feb. 18, 2020 -
GE Healthcare bulks up in 3D printing, robotics, patient monitoring
Projecting up to $20 billion in revenues this year, GE Healthcare is aiming to capitalize on the shift toward more precision in patient care with investments in Formlabs, CMR Surgical and Decisio Health.
By Susan Kelly • Dec. 2, 2019 -
Dexcom server outage rocks Type 1 diabetes community
The company announced late Monday it has restored services for its Dexcom Follow app to "near normal performance." Dexcom said it will work to improve communication methods with its customers.
By David Lim • Updated Dec. 3, 2019
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