FDA: Page 78
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It's official: EC confirms 2-year Eudamed delay
The database will now go live in May 2022, giving the industry a reprieve and more time to complete projects.
By Dana Elfin • Oct. 30, 2019 -
CMS proposes lifting restrictions on NGS cancer testing
The agency revised its proposed national coverage determination after receiving more than 80 comments, with potential plans to extend coverage of next generation sequencing tests to earlier-stage and hereditary cancers.
By Nick Paul Taylor • Oct. 30, 2019 -
Explore the Trendline➔
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 -
Jacob Bell/MedTech Dive
Surmodics gets breakthrough tag for critical limb ischemia device
The Minnesota medtech, which is also in the midst of testing a drug-coated balloon licensed by Abbott, now has a boost from FDA in bringing to market a sirolimus-delivering device designed to prevent amputation and death.
By Nick Paul Taylor • Oct. 30, 2019 -
Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body
BSI joins Dekra Germany as designated under the In Vitro Diagnostic Regulation ahead of its 2022 implementation date.
By Dana Elfin • Oct. 28, 2019 -
UK regulator mulls blocking Illumina's $1.2B PacBio takeover
The watchdog said the union "would result in a significant reduction of competition," leading some analysts to predict the deal won't go through.
By Nick Paul Taylor • Oct. 25, 2019 -
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 -
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
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