Jan. 14, 2026 — iSono Health has announced the commercial launch of ATUSA, an FDA-cleared, wearable and automated 3D quantitative breast ultrasound platform. Designed to bring high-quality imaging into everyday clinics, ATUSA unlocks the $14B U.S. breast imaging market by eliminating reliance on hard-to-find skilled sonographers and cost-prohibitive equipment.
A Paradigm Shift
Standard mammography often fails the 40 million American women with dense breast tissue, creating a massive diagnostic gap where cancers can remain hidden. It can be a painful experience and often exposes women to unnecessary X-ray radiation, leaving those of reproductive age with limited screening options. ATUSA can fundamentally change the economics and accessibility of breast health through a unique fusion of wearable hardware and cloud-based intelligence:
- Automated Scanning: Utilizing a wearable, hands-free accessory, ATUSA captures full 3D volumes in approximately two minutes per breast, roughly 10x faster than manual handheld ultrasound. This ensures consistent and repeatable images are generated, regardless of the operator's skill level.
- Point-of-Care Integration: The system empowers OB/GYNs and primary care providers to offer specialist-level imaging directly in their offices, generating standardized 3D whole-breast visualization directly at the point of care.
- USaaS Business Model: A scalable "Ultrasound-as-a-Service" model that combines the wearable hardware, cloud-based AI, and consumables to create a recurring revenue stream while lowering the barrier to entry for local clinics.
- Advanced "Sentient" AI: iSono Health is working to move beyond simple detection toward a "sentient partner" model, where the system utilizes acoustic biomarkers and machine learning to sense patient-specific needs and provide real-time diagnostic support.
"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 AUDIBLE Study: Validating the Future of Breast Health
A core pillar of the ATUSA launch is the initiation of the AUDIBLE Study, a multicenter clinical trial supported by a grant from the National Institutes of Health (NIH). This 800-patient study will evaluate the diagnostic performance of the ATUSA platform compared to traditional mammography and MRI.
Key objectives of the AUDIBLE Study include:
- AI Products Validation: Assessing the performance of iSono’s machine-learning algorithms in identifying and classifying abnormal masses.
- Operator Independence: Proving that the automated, wearable hardware provides consistent, high-fidelity 3D volumes regardless of the user's clinical background.
- The study is being conducted at leading medical institutions, including UC Davis, Veda Trials (Axia Women’s Health), and City of Hope, ensuring the technology is vetted by the nation's top oncology and radiology experts.
“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, M.D., Ph.D., M.P.H., Vice Chair of Global Health, Department of Radiology at 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.”
A graduate of Y Combinator and the Texas Medical Center Accelerator, iSono Health has gained significant industry recognition, including the HLTH 2025 Rising Star (Diagnostics) and the WISH 2024 Global Awards. Building on this commercial launch, the company is also announcing the opening of its Series A financing at its inaugural Next Horizon Summit during JPMorgan Week to accelerate global deployments and advance its AI-driven "sentient partner" roadmap toward machine-as-the-expert breast imaging robotics.
September 18, 2026 
