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JD Supra2d
Federal Court Vacates FDA's Final Rule on Laboratory-Developed Tests
On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and ...
STAT2dOpinion
Five priorities to remake the FDA in a time of deep uncertainty
Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...
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 ...
Medical Device Network on MSN9d
FDA approves Innoblative’s IDE for electrosurgical device for breast cancer
The US Food and Drug Administration (FDA) has granted approval for Innoblative Designs' investigational device exemption (IDE ...
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 ...
Newswire18d
FDA Watch: The Quiet Gold Rush in AI-Powered Medical Devices
The company plans to submit the data to the FDA by mid-2025, aiming for De Novo Clearance and rapid commercialization. GE HealthCare Technologies Inc. (NASDAQ: GEHC) recently unveiled its new ...
USA Today20d
Trump administration cuts FDA staff handling bird flu outbreaks
The job eliminations would not affect drug, medical device or food reviewers, nor would they affect inspectors, the fact sheet said. But in a statement, Dr. Sandra Faeh, president of the American ...