FDA clears iSonos automated, wearable 3D breast ultrasound system
Summary
iSono Health announced today that the FDA cleared its Atusa system for whole-breast ultrasound imaging. “We founded iSono Health with the vision to enable earlier diagnosis and treatment for breast cancer to save women’s lives, and this FDA clearance is a major step to fulfilling that vision.” iSono Health plans for several further FDA submissions with its technology as it is currently conducting prospective case collection studies to validate deep learning modules integrated with Atusa software to aid clinicians in the localization and classification of breast lesions. The company is supported by a National Science Foundation SBIR grant, Y Combinator, Foothill Ventures, Draper Associates, Plexo Capital, ATO Ventures, Camford Capital, as well as JLABs, Texas Medical Center Innovation and other top medical centers, it said. “Clinicians and women worldwide need high-quality breast imaging that is accessible and efficient at scale, without the need for highly skilled operators,” Ziaei added. “The portable and automated Atusa system stands alone in comparison to other ultrasound offerings in promising to address that need.