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When AI In Medical Devices Evolves Faster Than Regulations: How Do We Keep Up?
The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.
AI in Software as Medical Devices (SaMD): Navigating Patent and Regulatory Challenges in the US, Europe
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...
MedTech Dive4d
A judge blocked the FDA’s plan to regulate LDTs. What now?
One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...
MedPage Today on MSN11d
At House Hearing, Hemp Industry Begs for More FDA Regulation While Others Seek Less
Less regulation was also the focus of committee chair Rep. James Comer (R-Ky.). "The Biden administration stifled innovation ...
JD Supra4d
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court ...
Minneapolis Star Tribune on MSN11d
As FDA slashes workforce, number of new medical devices reaching the public has fallen
U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...
FDA: Job cuts at US health agency raises concerns over drug approvals
The US FDA is coping with a series of Trump-imposed job cuts. These are starting to hamper food safety and pharmaceutical ...
PharmiWeb2d
EndoUVtech Advances FDA Submission Preparations with Key Regulatory Leadership Appointment
FORT LAUDERDALE, FL / ACCESS Newswire / April 18, 2025 / EndoUVtech, a pioneering medical device company dedicated to transforming surgical stroke patient outcomes, today announced a crucial step in ...
National Law Review9d
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
JD Supra10d
AI Health Law & Policy: FDA’s rapidly evolving regulatory paradigms
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics.
MedPage Today on MSN9d
RFK Jr.'s Purge of FOIA Staff at FDA Spares People Working on COVID Vaccine Lawsuits
"FDA FOIA staff, including those working on litigation involving CBER, were impacted as part of HHS' reorganization," Nixon ...