Breast cancer is the most common cancer among women in the US. According to one estimate, about 30 percent of newly diagnosed cancer cases among women in 2022 would be breast cancer. Early diagnosis and treatment are the only way to save lives. A company co-founded by two female engineers has found an FDA-approved, automated way to do screen for breast cancer.
iSone Health has announced the FDA clearance of their wearable, 3D breast ultrasound device: ATUSA. It’s an automated, wearable ultrasound system that offers accurate and efficient 3D breast ultrasound imaging. The hands-free scan system offers an ultrasound without the need for a skilled operator. Who would have thought we’d be moving past the inadequacies of mammograms in such an automated and portable way?
The ATUSA system takes only two minutes to scan the entire breast and offers 3D visualization and cancer localization in radial, transverse, sagittal, and corneal views. The new ultrasound technology is independent of a skilled operator and has great implications for underserved populations. It has opened the door to automated remote monitoring in high-risk patients and empowers physicians to make more informed decisions in a timely fashion through insightful data. The portable device would increase access to care and provide a better patient experience.
The company is currently working to further improve its technology to help clinicians with the localization and classification of breast cancer.
We are thrilled at the FDA clearance of the automated breast scan device that could save millions of lives through early detection of breast cancer, especially through remote monitoring in the under-served areas.