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Radiology AI that clears Europe first faces a 17.5-month FDA wait
CE-first radiology AI waits a median 17.5 months for FDA clearance, an npj analysis finds.
FOCUS AI model automates the full OCT retina diagnostic path
The FOCUS system automates OCT retina diagnosis end to end and matches expert accuracy.
Emotion-aware LLM prompts sharpen mental health speech screening
Emotion-aware prompting lifts LLM speech screening for mental health risk in a new study.
FDA outlines three-stage path for digital measures in trials
FDA centers lay out a three-stage evidence path for wearable and sensor trial endpoints.
AI-discovered drugs still need a human name on the patent
US patent law still demands a human inventor even when AI did the creative work.
Study finds AI fingerprints on nine in ten biomedical papers
A preprint estimates that roughly nine in ten biomedical papers from December 2025 show signs of AI-assisted writing.
Study finds almost no FDA-cleared AI devices tested on outcomes
A PLOS Digital Health study finds only three of 1,357 FDA-cleared AI devices were ever tested on patient outcomes.
Blinded contest exposes uneven AI antibody design results
A blinded 29-team contest shows AI antibody tools can win in narrow tasks but fail at affinity prediction.