DeepHealth clears FDA review for ultrasound AI

DeepHealth won FDA 510(k) clearance for breast-ultrasound AI that it says localized lesions with greater than 98% accuracy in a 16-radiologist study, while improving cancer-detection sensitivity 8% and cutting interpretation time 37%. The company’s clearance announcement identifies the device as K260303 and says RadNet plans to deploy it across centers handling more than 700,000 potentially eligible studies a year. That scale moves clinical imaging AI beyond the general-purpose health assistant described in the analysis of ChatGPT Health’s medical-record push. Imaging operators should treat clearance as the start of procurement diligence, not the finish: the performance figures are company-reported, and reimbursement still depends on payer policy.