iSono Health Launches FDA-Cleared ATUSA Wearable Breast Ultrasound Platform
iSono Health has announced the commercial launch of ATUSA, an FDA-cleared, wearable, automated breast ultrasound platform designed for use in everyday clinical environments. The system captures standardized 3D breast images without relying on highly specialized sonographers, aiming to expand access to ultrasound-based breast imaging beyond traditional radiology settings.
ATUSA is positioned as an alternative and complement to mammography, particularly for women with dense breast tissue, where conventional X-ray imaging may have limitations. The wearable device performs automated scans in approximately two minutes per breast and generates repeatable 3D image sets regardless of operator experience. By integrating cloud-based software, the platform allows OB/GYNs and primary care providers to offer point-of-care breast imaging within their own practices.
The launch is accompanied by the initiation of the AUDIBLE Study, an NIH-supported, multicenter clinical trial enrolling approximately 800 patients. The study is designed to evaluate the diagnostic performance of the ATUSA platform compared with established imaging modalities, including mammography and MRI. Clinical sites include UC Davis, Veda Trials within Axia Women’s Health, and City of Hope, with a focus on assessing both image consistency and the performance of iSono’s machine-learning tools for lesion identification.
“ATUSA™ is a system-wide upgrade for women’s breast health,” said Neda Razavi, CEO of iSono Health. “We are putting the power of a world-class radiology suite into the hands of local clinicians, replacing slow, manual workflows with real-time diagnostic images at the point of care.” Independent experts have also highlighted the potential of operator-independent ultrasound technologies to improve screening access, particularly in community-based care settings.
iSono Health reports raising $14.7 million to date through a combination of venture financing and non-dilutive grants from the NIH, NSF, and NCI. The company is opening its Series A round during JPMorgan Healthcare Week to support broader commercialization and international deployment. As it enters 2026, iSono Health has begun onboarding paying clinics through an early partner program while continuing to build clinical evidence to support wider adoption of the ATUSA platform.
