iSono Health developed the Atusa system for portable, automated breast imaging. [Image courtesy of iSono Health]
iSono Health
iSono Health won FDA 510(k) clearance this year for its whole-breast ultrasound imaging system, Atusa.
South San Francisco, California–based iSono said the Atusa system is the world’s first automated and wearable 3D breast ultrasound. Breast cancer is the global leader of cancer deaths among women, with one in eight women diagnosed with breast cancer at some time during their lives.
“Clinicians and women worldwide need high-quality breast imaging that is accessible and efficient at scale, without the need for highly skilled operators,” iSono co-founder and CEO Maryam Ziaei said when announcing the clearance. “The portable and automated ATUSA system stands alone in comparison to other ultrasound offerings in promising to address that need.”
The portable system takes two minutes per breast to scan a patient’s entire breast volume for 3D visualization of tissue, without needing a trained ultrasound operator controlling the device. iSono plans additional FDA submissions as it studies deep learning models that can help clinicians locate and classify breast lesions.
Ziaei founded the company in 2015 with Chief Technology Officer Shadi Saberi. Both women had close friends who died of breast cancer.
