Subtle Medical vs Tempus AI Imaging

Subtle Medical's AiMIFY, developed with Bracco, targets contrast-enhanced brain MRI at a lower gadolinium dose, and the FDA list carries it as K240290. The company holds 11 clearances in all, the newest for SubtleHD-CT in May 2026, and covers MR, PET and CT with its SubtleHD line. No buyer weighs this against Tempus Pixel, because Subtle changes the scan and Pixel analyses the result. A neuroradiology unit trying to cut gadolinium or a PET program with a backlog is Subtle's customer. Pixel, formerly Arterys, goes to an oncology service that tracks segmented lesions across CT and MR studies with RECIST-style reports, or to a cardiac MR program. Its lung, breast and prostate tools run on third-party engines, among them iCAD's ProFound AI and Quibim's prostate software. The updated Pixel cleared as a special 510(k), K252539, in September 2025.