The U.S. FDA has granted 510(k) clearance to a breast ultrasound artificial intelligence solution developed by RadNet subsidiary DeepHealth. This AI tool automates the detection, characterization, and reporting of lesions, streamlining workflows for radiologists and sonographers. Following validation through a study with 16 certified radiologists, the product is now available commercially and eligible for reimbursement under a Category 3 CPT code. RadNet aims to implement this technology across its network of 440 centers by the end of the year. Breast ultrasound is an essential part of cancer care, with RadNet performing approximately 700,000 procedures annually. The new solution is anticipated to enhance standardization in workflows and improve consistency in breast imaging.
Fri, 31 Jul 2026 06:36:35 GMT | Radiology Business