The FDA is the US federal agency that reviews and regulates drugs, medical devices and related products. Recent coverage covers its push to regulate generative AI, which radiology societies have responded to, and a Crowell & Moring report on legal risks of AI-generated drug evidence. The agency also cleared Tumor Site Risk, an AI tool that analyzes breast MRI scans to estimate cancer recurrence risk. A Management Science study proposes a human-plus-algorithm approach to prioritize device reviews.
CASRAI releases guide on radiology AI uses and rulesCASRAI released a radiology AI guide covering FDA regulations, GMLP standards, clinical imaging workflows, and multisociety governance frameworks. It stresses AI as clinical decision support that detects anomalies and prioritizes emergent cases, while licensed radiologists retain sole diagnostic responsibility.
Radiology societies weigh in on FDA push to regulate generative AIRadiology societies have responded to the FDA's push to regulate generative AI. The article does not detail their specific recommendations or any regulatory timeline.
Report flags legal risks of AI-generated drug evidenceA Crowell & Moring client alert says probabilistic AI models in drug discovery can produce plausible-but-wrong outputs that affect regulatory submissions, trial integrity and legal liability. It lists five risks: hallucinations, unrepresentative training data, opaque reasoning, input sensitivity and adversarial manipulation of training data, and urges experimental validation, human oversight and preparation for FDA and EU guidance.
AI Tool Tumor Site Risk Wins FDA ClearanceThe FDA has cleared Tumor Site Risk, an AI tool that analyzes existing breast MRI scans to estimate a patient's risk of cancer returning five or ten years after diagnosis. With nearly 400,000 US women diagnosed with breast cancer annually, it helps patients better understand recurrence likelihood.
Study: AI could cut medical device recallsA Management Science study proposes a human-plus-algorithm approach to help the FDA prioritize higher-risk medical device reviews. Simulations show a 40.5% workload reduction, a 32.9% recall-rate improvement, and up to $1.7B in annual savings.
The A.I. Daily