The Latest
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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%.
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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.
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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The draft guidance would permit manufacturers to use a set of performance criteria to demonstrate substantial equivalence, instead of a direct comparison to a predicate device.
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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.
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Roche MRSA test wins FDA De Novo OK
The agency said the novel diagnostic technology can deliver results in as few as five hours, versus the one to two day wait with conventional methods.
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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 altogether. With more than 80% of devices cleared through the pathway, small changes can be consequential to improving product safety.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Philips to offer Paige.AI's prostate cancer detection tech
Weeks after Memorial Sloan Kettering Cancer Center spinout Paige.AI won a CE mark for its diagnostic tools, Philips announced it will combine its own digital pathology capabilities with the startup's prostate cancer product.
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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.
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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.
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Sens. Wyden, Booker push CMS, FTC, insurers on bias in algorithms
The lawmakers want an investigation into how use of the algorithms may lead to discrimination against marginalized populations.
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FDA grants breakthrough status to eye-tracking Parkinson's test
The diagnostic test is designed to detect persistent ocular tremors, a symptom research suggests appears early and is pervasive in Parkinson's patients.
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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.
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Hospitals sue HHS, warning price transparency rule would chill competition, crash computers
An agency spokeswoman shot back that hospitals "should be ashamed that they aren't willing to provide American patients the cost of a service before they purchase it."
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Trump FDA nominee Hahn advanced by Senate HELP Committee 18-5
Ranking Member Patty Murray said she would not support the nomination due to a lack of a commitment to back regulations to take non-tobacco flavored e-cigarettes that have not gone under FDA review off the market.
UPDATED: Dec. 3, 2019 at 11:22 a.m. -
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.
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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.
