New 3D Breast Ultrasound Imaging Device Gets FDA 510(k) Clearance

A new modality that may redefine the efficiency of breast imaging has received 510(k) clearance from the Food and Drug Administration (FDA). The new ATUSA™ System, a portable whole breast ultrasound device, can provide 3D imaging in two minutes, according to iSono Health, the manufacturer of the device.

Featuring intuitive software designed to integrate with machine learning models, the ATUSA system provides efficient automated scans of breast volume and analysis. Emphasizing patient comfort, the ultrasound device also offers a compact portability with a unique wearable accessory.

“A portable and automated whole breast ultrasound augmented with machine learning would be the most practical technology to reduce breast cancer mortality globally, specifically in countries with limited resources. In developed countries, ultrasound has proven effective as an adjunct to mammography to improve breast cancer diagnosis in women with dense breasts,” noted Mohammad Eghtedari, M.D., Ph.D., a breast radiologist and assistant professor at the University of California-San Diego. “I believe iSono Health’s automated and portable technology will improve access to breast care for women worldwide and empower physicians with insightful data to make more informed clinical decisions.

The ATUSA system also facilitates consistent, reproducible accuracy, regardless of the experience level of the physician, Maryam Ziaei, Ph.D., the co-founder and CEO of iSonoHealth

“Clinicians and women worldwide need high quality breast imaging that is accessible and efficient at scale without the need for highly skilled operators,” emphasized Maryam Ziaei, Ph.D, the co-founder and CEO of iSonoHealth. “The portable and automated ATUSA system stands alone in comparison to other ultrasound offerings in promising to address that need.”