382,640 women will be diagnosed with breast cancer in 2026. 42,140 will die from it. And for decades, the core problem has been the same: breast ultrasound is one of the most operator-dependent procedures in all of radiology, with significant variability in how images are acquired, how lesions are characterized, and how reports are written. Different sonographers. Different reads. Different outcomes for the same patient.
On July 30, 2026, DeepHealth - a wholly owned subsidiary of RadNet (NASDAQ: RDNT) - received FDA 510(k) clearance for an AI-powered breast ultrasound platform that handles lesion detection, characterization, and report generation in a single automated workflow. The clinical validation numbers are not incremental. They are structural.
This is not a flagging tool that highlights areas of concern and hands the rest back to a radiologist. This is end-to-end AI automation of an entire imaging modality. And it cleared the FDA. It has reimbursement codes. It is going live acro…
