ATUSA is an advanced automated 3D breast ultrasound system designed to provide an accessible and personalised breast imaging solution for use at the point of care


iSono Health’s ATUSA wearable 3D breast ultrasound. (Photo: iSono Health, Inc.)

iSono Health has received the US Food and Drug Administration (FDA) approval for ATUSA System, its automated wearable ultrasound system for breast imaging.

ATUSA System comprises a unique wearable accessory and an intuitive software to deliver automated image acquisition and analysis.

It leverages the company’s patented technology to automatically scan the entire breast volume and enables 3D visualisation of the breast tissue, within two minutes.

The wearable breast imaging system makes 3D breast ultrasound imaging accessible to patients and physicians at the point of care, said the medical imaging company.

iSono Health co-founder and CEO Maryam Ziaei said: “We founded iSono Health with the vision to enable earlier diagnosis and treatment for breast cancer to save women’s lives, and this FDA clearance is a major step to fulfilling that vision.

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

“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.”

According to iSono Health, ATUSA has been designed to provide enhanced efficiency, consistent accuracy and a comfortable patient experience.

The system can be easily integrated with advanced machine learning models that provide physicians with a complete set of tools for decision making and patient management.

Currently, the company is conducting case collection studies to further validate the integration of several deep learning models with ATUSA software for the localisation and classification of breast lesions.

iSono Health is backed by a National Science Foundation SBIR grant, Y Combinator, Foothill Ventures, Draper Associates, Plexo Capital, ATO Ventures, Camford Capital, along with JLABs and Texas Medical Centre Innovation, among other medical centres.

University of California San Diego assistant professor Mohammad Eghtedari said: “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.

“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.”