News

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 ...
MedPage Today on MSN8d
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 ...
NewsBytes1h
Neuralink rival gets FDA clearance for its brain implant
Precision Neuroscience has received FDA approval for a key component of its brain-computer interface, aimed at restoring ...
MedTech Dive1d
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 ...
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 ...
National Law Review6d
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 ...
Minneapolis Star Tribune on MSN9d
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 ...
JD Supra1d
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”) has vacated the ...
JD Supra1d
Addressing Data Integrity Challenges in Medical Device Submissions
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
BioPharma Dive15d
FDA device office hit in HHS layoffs
Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.
FDA Cuts Threaten New Drugs as Reviewers Saddled With Extra Jobs
HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...