FDA Device Explorer

An analysis of all 1,483 AI/ML-flagged records in the Innolitics FDA Device Explorer found 88 AI software-as-a-medical-device clearances that cite a predicate which is not SaMD, and 50 of those are ca…

One in five AI/ML 510(k) clearances cites a predicate under a different product code, with 85 devices predicated on a different body region, 35 swapping imaging modality, and 122 crossing 21 CFR regul…