Topics & companies
US FDA
8 items mentioning this organisation across 4 issues, newest first.
Matched conservatively on the item headline and summary (explicit names only). All topics and companies.
21 October 2026
FDA official: GenAI tools may need physician-style assessment
At AdvaMed's MedTech Conference in Boston, Rick Abramson of FDA's Digital Health Center of Excellence said the agency received more than 300 comments on its GenAI device discussion paper and intends to draft policy.
FDA outlines AI device modification scenarios under PCCPs
Two hypothetical examples show a hospital-specific sepsis alert being fine-tuned on local data and a cardiac arrhythmia detector being retrained automatically, both within predetermined change control plans that avoid…
20 October 2026
FDA clears TumorSight Risk for HR+, HER2– breast cancer
The 510(k) covers an AI score estimating 5- and 10-year recurrence-free survival from routine breast MRI, pathology and clinical data in stage I–IIIA disease. In 2,138 patients the high-risk group had a hazard ratio of…
AMA sets out a path for FDA oversight of genAI
The AMA backs a least-burdensome, risk-based approach that protects patients while supporting responsible device innovation.
AHA comments to FDA on genAI-enabled devices
Hospitals filed feedback on the FDA discussion paper (docket FDA-2026-N-7874), whose comment period closed on 19 October.
Chatbot risks and regulatory oversight in telemedicine
AI chatbots test how medical licensing, consumer protection, FDA oversight and prescribing rules apply to digital care.
19 October 2026
FDA: regulating generative-AI medical devices
Discussion paper and request for feedback on generative-AI devices (docket FDA-2026-N-7874).
18 October 2026
SimBioSys won FDA clearance for TumorSight Risk, an Nvidia-powered tool that uses MRI data to predict the risk of breast-cancer recurrence.