In a move that could redefine the landscape of women’s preventative health, medical technology pioneer iSono Health announced the commercial launch of ATUSA, the world’s first FDA-cleared, wearable, and automated 3D breast ultrasound platform.
The announcement, made during the Next Horizon Summit at JPMorgan Healthcare Week, marks a significant shift in how breast imaging is delivered. By combining wearable hardware with cloud-based artificial intelligence, ATUSA aims to bridge the diagnostic gap for the 40 million American women with dense breast tissue – a group for whom traditional mammography is often less effective.
High-Tech Imaging at the Point of Care
Unlike traditional ultrasound, which requires a highly skilled sonographer and can take up to 20 minutes of manual scanning, the ATUSA system uses a hands-free, wearable accessory to capture full 3D breast volumes in just 2 minutes. Because the process is automated, the image quality is no longer dependent on the operator’s skill, allowing primary care providers and OB/GYNs to offer specialist-level imaging directly in their offices.
“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.”
Addressing the “Dense Breast” Challenge
For women with dense breasts, cancers can often be “masked” on a mammogram, appearing white against white tissue. Ultrasound is the gold standard for supplemental screening, but its availability has long been limited by the shortage of trained technicians and the high cost of equipment.
iSono Health’s “Ultrasound-as-a-Service” (USaaS) model seeks to lower these barriers, providing clinics with the hardware, consumables, and cloud-based AI needed to perform screenings without massive upfront capital investment.
Clinical Validation: The AUDIBLE Study
Coinciding with the commercial launch, iSono Health has initiated the “AUDIBLE Study,” a large-scale, multicenter clinical trial supported by the National Institutes of Health (NIH). The 800-patient study will compare the diagnostic performance of ATUSA with that of traditional mammography and MRI at leading institutions, including UC Davis, Veda Trials (Axia Women’s Health), and City of Hope.
The trial aims to validate iSono’s machine-learning algorithms, which are being developed to serve as a “sentient partner” for doctors, assisting in the identification and classification of abnormal masses in real time.
Financial Momentum
The launch comes on the heels of significant financial growth for the company. iSono Health has raised $14.7 million in venture and SBIR funding to date, including a recent $3 million Seed Preferred round led by Draper Associates and Transform VC.
With the commercial rollout now underway, the company has officially opened its Series A financing round to accelerate global deployments.
“2025 was our inflection point,” Razavi noted. “We’ve moved from R&D into commercialization, accelerating deployment while generating the clinical evidence health systems and physicians expect.”
