iSono Health Launches Wearable 3D Breast Ultrasound Platform, Opens Series A to Expand Commercial Reach

iSono Health has officially launched its FDA-cleared ATUSA™ platform, a wearable and automated 3D breast ultrasound system designed to make high-quality breast imaging more accessible and cost-effective. The platform’s commercial debut comes as the company opens its Series A financing round, marking a new growth phase focused on scaling deployments and advancing its AI-driven imaging roadmap.

Positioned as a solution to the longstanding gaps in breast cancer screening—particularly for the more than 40 million women in the U.S. with dense breast tissue—ATUSA™ delivers operator-independent, full-volume 3D scans in about two minutes per breast. The hands-free system is designed to enable primary care and OB/GYN providers to offer diagnostic-quality imaging directly in their clinics, reducing reliance on traditional ultrasound equipment and specialized technicians.

“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.”

The product operates under a scalable “Ultrasound-as-a-Service” (USaaS) model, combining wearable hardware, cloud-based AI, and consumables to generate recurring revenue and lower the cost of adoption for community clinics. According to the company, this model opens up access to the $14 billion U.S. breast imaging market by simplifying integration and reducing operational complexity.

The launch is supported by the ongoing AUDIBLE Study, a multicenter clinical trial backed by the National Institutes of Health. The 800-patient study is designed to compare ATUSA’s performance with traditional imaging methods like mammography and MRI, while also evaluating the platform’s AI for lesion detection and the consistency of imaging results across clinical users. Trial sites include UC Davis, Veda Trials (Axia Women’s Health), and City of Hope.

“What we need are imaging solutions that are easy to use, require minimal training, and can be brought directly into communities,” said Dr. John R. Scheel of Vanderbilt University Medical Center. “Wearable, operator-independent ultrasound technologies have the potential to dramatically improve access, speed, and accuracy, especially for women with dense breasts.”

iSono Health has raised $14.7 million to date, including $3 million in 2025 from Draper Associates, Transform VC, and other investors. The company has also secured $3.7 million in non-dilutive grant funding from agencies including NIH, NSF, and NCI. With paying clinics already on board through its Pioneering Partner Program and a growing internal team, the company says it is well positioned for its next stage of growth.

The Series A round, now open, is expected to support broader commercialization and development of iSono’s long-term AI roadmap, which includes a move toward “sentient partner” robotics designed to assist with real-time, patient-specific breast diagnostics.