The US FDA has cleared TumorSight Risk from Chicago company SimBioSys, an AI tool that estimates the risk of breast cancer coming back using MRI scans. SimBioSys announced the clearance on 15 October, CURE reported.
It gives five and ten year risk scores for stage 1 to 3A hormone-receptor-positive, HER2-negative breast cancer. In a review of past records from 2,129 patients, those rated high risk had 3.3 times the recurrence rate of those rated low risk.
There is no evidence yet that using it changes patient outcomes.
Why it matters: it gives an extra risk estimate from scans patients already have, with no new test.