FDA: Page 74
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Fresenius gets breakthrough tag for clot-preventing dialysis device
The dialysis services giant is testing a system that features a polymer designed to cut the risk of blood clotting without the use of medication.
By Nick Paul Taylor • Oct. 25, 2019 -
Device to ID obstructions in post-PCI patients wins breakthrough status
Swiss startup CorFlow Therapeutics created the device to both assess and treat microvascular obstruction in patients after percutaneous coronary intervention.
By Nick Paul Taylor • Oct. 24, 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 -
FDA pitches black box warning for breast implants
The agency said it heard "loud and clear" worries of patients who testified at an advisory panel regarding a potential link between certain implants and a form of lymphoma, as well as other adverse events.
By Kim Dixon • Oct. 23, 2019 -
Device to halt knee implant infections gets breakthrough tag
Garwood Medical Devices is looking to raise $3 million in Series B funding by the end of this year.
By Nick Paul Taylor • Oct. 23, 2019 -
Canon gets FDA nod for AI tech to enhance CT images
Rising use of CT scans, which expose patients to far more radiation than X-rays, has intensified focus on the risks of the imaging technique, particularly in the pediatric population.
By Nick Paul Taylor • Oct. 22, 2019 -
Sens. Warren, Cassidy press FDA on difference between servicing and remanufacturing
The agency does not require servicers, who face fewer regulatory requirements than remanufacturers, to register with FDA.
By David Lim • Oct. 18, 2019 -
AdvaMed lobbies Trump to repeal medical device tax (again)
The trade organization has successfully delayed the levy for years, but the latest moratorium expires at year's end.
By Nick Paul Taylor • Oct. 18, 2019 -
Key committee pitches adding UDIs to payer claim forms, called 'huge step'
If a unique device identifier is captured when a high-risk product is implanted, providers will be able to detect complications more quickly, Joe Drozda, the director of outcomes research at Mercy Health, told MedTech Dive.
By David Lim • Oct. 17, 2019 -
ViewRay bucks payment fears in field dubbed 'not dead' yet
The radiation oncology company received eight new orders for its MRI-guided Linac, easily beating Jefferies' forecast.
By Nick Paul Taylor • Oct. 16, 2019 -
Two weeks from Brexit deadline, UK floats device contingency
A no-deal Brexit would not meet any of MedTech Europe's four priorities.
By Nick Paul Taylor • Oct. 15, 2019 -
Hospitals, manufacturers could donate cybersecurity software under proposed regs
With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.
By David Lim • Oct. 14, 2019 -
Medical software makers get new guidance on MDR, IVDR
The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.
By Dana Elfin • Oct. 14, 2019 -
FDA clears first rapid Ebola virus diagnostic
Risk of flare up remains, but the United Nations called the outbreak responsible for killing 2,100 people over 14 months in the Democratic Republic of the Congo "significantly contained."
By Nick Paul Taylor • Oct. 11, 2019 -
GAO finds low uptake of disposable wound care devices
Advocates of the products, sold by companies including Acelity and Smith & Nephew, argue the size and cost make them preferable to durable devices when treating small wounds.
By Nick Paul Taylor • Oct. 11, 2019 -
CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities
The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.
By David Lim • Oct. 11, 2019 -
HHS hesitant to include implantable medical devices in Anti-Kickback safe harbor
The government appears to be considering various methods to exclude device manufacturers from its care coordination safe harbor while allowing digital health technologies used to remotely monitor patients to take advantage of it.
By David Lim • Oct. 10, 2019 -
Dekra Germany is first notified body designated under IVDR
The designation of the first notified body to review in vitro diagnostics means manufacturers can start working toward certification by the May 2022 deadline.
By Dana Elfin • Oct. 10, 2019 -
FDA makes final recommendations on vascular device labels
The guidance documents address issues such as the risk of coatings separating from devices.
By Nick Paul Taylor • Oct. 10, 2019 -
Experimental cancer IVD trial guidance finalized
AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.
By Nick Paul Taylor • Oct. 10, 2019 -
Alex Wong via Getty Images
HHS pitches sweeping revamp of Anti-Kickback Statute, Stark Law
Several new safe harbors are proposed to encourage value-based care, allow patient engagement through furnishing of tools and supports, and permit certain remuneration in some CMS-sponsored models.
By David Lim • Oct. 9, 2019 -
AI clinical support opens physicians to potential liabilities: JAMA
Legal considerations for doctors using clinical decision support software come amid challenges for regulators attempting to define a framework to oversee the emerging technologies.
By David Lim • Oct. 7, 2019 -
IMDRF cybersecurity guidance favors total product life cycle approach
The International Medical Device Regulators Forum's draft mirrors U.S. regulators' support for a total product life cycle strategy, but does not include a tiered approach to categorizing risk laid out by FDA last year.
By Nick Paul Taylor • Oct. 3, 2019 -
Some Class I devices could get 4 extra years to comply with EU MDR
The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday in advance of an expected vote on a corrigendum to amend or modify some parts of major upcoming EU regulatory changes.
By Dana Elfin • Oct. 2, 2019 -
DME industry pans CMS' gap-fill proposal, but agrees current system is "fundamentally flawed"
CMS' proposed framework to compare new technology to older items is not sufficiently fleshed out and isn't transparent enough, the American Association for Homecare said.
By David Lim • Oct. 2, 2019 -
Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities
The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."
By David Lim • Sept. 30, 2019
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