FDA Grants 510(k) Clearance to iSono Health's Atusa Wearable 3D Breast Ultrasound

South San Francisco, Calif.-based iSono Health has received the FDA’s 510(k) marketing clearance for its Atusa system for breast imaging.

The device is a compact whole breast ultrasound system with a wearable accessory and software for automated image acquisition and analysis.

Atusa provides ultrasound imaging at the point of care. The portable system scans the entire breast in two minutes and provides 3D visualization of the tissue. It is designed to be integrated with machine learning to help physicians with patient management, the company said.