South San Francisco, California–based iSono designed Atusa as a first-of-its-kind, compact, automated whole-breast ultrasound system with a unique wearable accessory and intuitive software for automated image acquisition and analysis.
According to a news release, Atusa’s patented technology makes 3D breast ultrasound imaging accessible to patients and physicians at the point of care, with an automatic scan of the entire breast volume to offer 3D visualization of the breast tissue in just two minutes, independent of operator expertise.
“Breast cancer is the leading cause of cancer death among women worldwide, and one in eight women will be diagnosed with breast cancer in their lifetime,” iSono Health co-founder and CEO Maryam Ziaei said in the release. “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. We are thrilled to be able to get Atusa into the market and have the opportunity to help save lives.”