Aidoc

Sutter Health, a Sacramento-based not-for-profit healthcare system serving more than 3.5 million patients across Northern and Central California, has expanded its clinical use of artificial intelligen…

A new analysis by Innolitics of 890 FDA clearance letters for AI/ML software-as-a-medical-device authorizations through August 2026 finds that 57 percent name an in-house regulatory or quality person,…

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…