After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
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 approval is widely regarded as a benchmark of quality for medical devices. However, concerns persist regarding its regulatory framework for digital mental health devices. This perspective article ...
Let's face it: Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost ...
Artificial intelligence (AI) has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...
Two members of congress called for the U.S. Food and Drug Administration to "overhaul and streamline" its recalls and 510(k) premarket notification databases, in a letter sent to Director Jeffrey ...
Artificial intelligence (AI) has the potential to transform healthcare. While evidence suggests that AI can approach or even surpass human performance 1,2, and potentially even develop unexpected or ...
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