iSono Health Launches Wearable AI-Powered 3D Breast Ultrasound Platform
Published: 16 Jan 2026
Author: Precedence Research
iSono Health has stated that it has made a commercial release of ATUSA, an FDA-cleared wearable. This is a completely automated 3D quantitative breast ultrasound system, which is aimed at redefining the provision of breast imaging in routine clinical practices.
ATUSA enables many more to have access to the very lucrative U.S. breast imaging market, estimated at 14 billion. They are eliminating the reliance on a highly specialized group of sonographers and cutting out the necessity to install expansive and costly imaging infrastructure. The platform would introduce high-quality diagnostic imaging to clinics in the OB/GYN and primary care settings.
ATUSA has reached a pivotal point, with traditional mammography still failing to detect millions of women with dense breast tissue, with cancers being more likely to go undetected. Mammograms are also uncomfortable, and it exposes patients to ionizing radiation. This narrows down its applicability to frequent screening, particularly in women of reproductive age. To neutralize these long-standing challenges, ATUSA proposes a new approach to the solution by combining the wearable hardware, automation, and cloud-based intelligence.
The ATUSA is based at its heart on an ultrasound device that is wearable and hands-free to operate in a scanning mode that is automated. It takes about two minutes to scan the entire high-resolution 3D volumes of the two breasts, which is ten times quicker than the traditional handheld ultrasound tests. Since the scanning procedure is entirely automated, the quality and consistency of images are no longer determined by the capabilities and experience of a clinician.
This allows to rely on dependable diagnostics in a broad scope of care facilities. The automation provides a capability to obtain repeatable, standardized imaging results, which could be compared across time, enhancing longitudinal patient monitoring. Furthermore, the ATUSA is a significant move towards the transformation of breast health screening, as healthcare systems around the world overlook scalable patient-centric diagnostic solutions.
Executive Statement
Neda Razavi, CEO, iSono Health, stated, “ATUSA represents a system-wide upgrade for women’s breast health. We are placing the capabilities of a world-class radiology suite directly into the hands of local clinicians, replacing slow, manual workflows with fast, automated, and highly reliable diagnostic imaging at the point of care.”