FDA Clears Wearable 3D Breast Ultrasound System

iSono Health ATUSA System
iSono Health ATUSA System
iSono Health

iSono Health's ATUSA System has been cleared by the U.S. Food and Drug Administration (FDA).

The ATUSA System is a compact automated whole breast ultrasound system, with a wearable accessory and a software for automated image acquisition and analysis.

"Clinicians and women worldwide need high quality breast imaging that is accessible and efficient at scale, without the need for highly skilled operators," said said Maryam Ziaei, PhD, co-founder and CEO of iSono Health. "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."

The portable ATUSA system scans the entire breast volume, independent of operator expertise and offers 3D visualization of the breast tissue.

“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 been proven effective as an adjunct to mammography to improve breast cancer diagnosis in women with dense breasts,” said Mohammad Eghtedari, MD, PhD, a breast radiologist and an assistant professor at 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.”

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