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As FDA slashes workforce, number of new medical devices reaching the public has fallenMINNEAPOLIS — U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a ...
On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and ...
The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.
One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics.
The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development ...
On April 7, 2025, the U.S. Food and Drug Administration ("FDA" or "the agency"), classified Q'Apel Medical, Inc.'s ("Q'Apel" or "the company") voluntary recall of 1,617 units of its 072 Aspiration ...
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...
The Food and Drug Administration is reinstating telework for staff who review drugs, medical devices, and tobacco, according ...
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