JD Supra

FDA medical device inspections in 2025: What we're seeing, what we expected, and why you need the right expertise now

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 ...
Medical Xpress

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 ...
Fierce Healthcare

Lawmakers want FDA devices databases overhauled

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 ...
Nature

FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges

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 ...
Nature

How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations

We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy capturing key variations in clinical and AI-related features. Quantitative image analysis remains the most ...