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To Be (a device) Or Not To Be. That’s The Legal Question
Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.
Apple Watch Feature Qualified As FDA Device Development Tool
The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.
Expert Proposes AI Device Reimbursement Model ‘Like Netflix’
Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement.
Robotic-Assisted Treatment For Enlarged Prostate Shows Promising Results
A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.
ORA’s Chief Says Without Additional Funding, Inspections Are In Jeopardy
Without additional funding from Congress, the FDA’s ORA is facing challenges in retaining and hiring new staff, which will impact inspections, said ORA’s chief Michael Rogers during a webinar.
ICER Debuts Clinical Trial Diversity Assessment Framework
The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.
Attorney: Proposed Data Privacy Law Would Ultimately Reduce Regulatory Burden
Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”
Senseonics Wins Marketing Authorization For Novel Insulin Delivery System
The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.
Global Medtech Guidance Tracker: April 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.
Recalls Round-Up: Class 1s For BioMérieux, Fresenius, Draeger, More
A spate of recalls released in recent days follow problems with antibiotic test kits, dialysis tubing, an anesthesia system and infusion pumps. About 4,000 complaints have been reported tied to the recalls.
New Guidance For Breast Cancer Screening Drops Age Of First Scan To 40
New guidelines for breast cancer screening age and frequency have been lowered to align with standards from the American Cancer Society, but there are still debates over some of the recommendations.
CDRH’s AR/VR Home Space Will Serve As An ‘Idea Lab’ For Device Stakeholders
The US FDA’s new initiative to create an idea lab for medical device use at home will benefit device manufacturers, patients and policymakers alike.
It’s Official: FDA Drops Final Rule On LDTs
After much anticipation, the US FDA is set to publish its controversial final rule for regulating laboratory developed tests, which places the tests under the same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.
News We're Watching: LDT Final Rule Near Publication, Zimmer ROSA Used In Shoulder Surgery, $60M For Menopause Clinic
This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer Biomet announced that its ROSA surgical robot had been used in shoulder replacement surgery for the first time; and a virtual menopause clinic closed out a $60M fundraising round.
Epitel Gets 510(k) Clearance On Remote EEG Technology
The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.
Rise In Class I Device Recalls A ‘Grave Concern,’ Says FDA’s Anne Reid
The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.
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