FDA Clears Automated, Wearable 3D Breast Ultrasound Device

iSono Health's wearable 3D breast ultrasound.
In 2 minutes, the portable ATUSA system automatically scans the entire breast volume and provides 3D visualization of the breast tissue.

The Food and Drug Administration (FDA) has granted 510(k) clearance to ATUSA™, an ultrasound system designed to capture imaging of the breast at the point of care.

The ATUSA system includes a 3D ultrasound scanner, a wearable accessory, and a Windows application for automated image acquisition and analysis. In 2 minutes, the portable ATUSA system provides real-time 2D images of the breast tissue at the point of care without requiring an ultrasound operator. The system then allows for interactive 3D whole breast visualization and lesion localization in radial, coronal, sagittal, and transverse views through a secure web application for remote viewing.

Acquired images are saved locally, and when connected to the internet, are backed up to a HIPAA-compliant secure cloud storage. While a radiologist or ultrasound technician is not required to acquire the images, interpretation of the images should be done by a physician trained in breast ultrasound.

“Clinicians and women worldwide need high quality breast imaging that is accessible and efficient at scale, without the need for highly skilled operators,” 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.”


  1. FDA clears iSono Health’s ATUSA™, the world’s first automated and wearable 3D breast ultrasound. News release. iSono Health, Inc. Accessed May 3, 2022. https://www.businesswire.com/news/home/20220503005316/en/FDA-Clears-iSono-Healths-ATUSA%E2%84%A2-the-World%E2%80%99s-First-Automated-and-Wearable-3D-Breast-Ultrasound
  2. iSono Health. Accessed May 3, 2022. https://isonohealth.com/