DeepHealth received FDA 510(k) clearance for Chest XRay, a computer aided detection tool built on a foundation model that detects and localizes abnormalities on chest radiographs. It is the next version of the technology DeepHealth acquired with Gleamer, it is commercially available in the US now, and existing customers are eligible for the update.
Our readA foundation model clearance matters because one model covers many findings, rather than one narrow algorithm per finding. Radiology groups should ask exactly which findings the 510(k) covers, since marketing for foundation models tends to run ahead of the cleared indications.