DeepHealth has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its DeepHealth Breast Ultrasound software.
The AI-powered application automates lesion detection, characterization, and reporting, according to the RadNet subsidiary, which reported greater than 98% accuracy in localizing breast lesions, an 8% improvement in sensitivity for breast cancer detection, and a 37% reduction in radiologist interpretation time.
DeepHealth Breast Ultrasound is now commercially available in the U.S. and is expected to be implemented across RadNet’s network of imaging centers by the end of the year, the company said.