FDA clears iSono’s automated, wearable 3D breast ultrasound system

[Image from iSono Health]iSono Health announced today that the FDA cleared its Atusa system for whole-breast ultrasound imaging.

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 dia…

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