Develops ATUSA, an FDA 510(k)-cleared portable, automated 3D breast ultrasound system for point-of-care imaging
Develops ATUSA, an FDA 510(k)-cleared portable, automated 3D breast ultrasound system for point-of-care imaging. Its wearable accessory and software enable hands-free whole-breast scans, image visualization and lesion localization, with cloud-based remote access for longitudinal monitoring. AI features are described as investigational and not demonstrated safe or effective for clinical use.