iSono Health announced it has commercially launched ATUSA, an FDA-cleared, wearable, automated 3D quantitative breast ultrasound platform that the company is positioning as a way to bring high-quality breast imaging into everyday clinics without relying on scarce sonographers or expensive traditional ultrasound systems.
The Y Combinator and Texas Medical Center Accelerator alum said ATUSA uses a hands-free wearable accessory to capture full 3D breast volumes in about 2 minutes per breast—an approach the company claims is roughly 10 times faster than manual handheld ultrasound—while generating standardized images that are consistent regardless of operator skill level. iSono Health said the platform is designed for use in point-of-care settings such as OB/GYN and primary care offices, with an aim of offering “specialist-level” imaging directly in routine clinics.
The company is also pitching a recurring-revenue “Ultrasound-as-a-Service” model that bundles wearable hardware with cloud-based AI and consumables, which it says lowers adoption barriers for local clinics while creating ongoing revenue streams. iSono Health said it is pursuing a longer-term roadmap for AI-driven diagnostic support, describing it as a “sentient partner,” though it noted that its AI is still in development and not yet FDA-cleared.
iSono Health framed the launch around screening challenges for women with dense breast tissue, arguing that mammography can miss cancers in this population and that alternative imaging options can be harder to access. The company said it is initiating the AUDIBLE Study, an 800-patient, multicenter clinical trial supported by a National Institutes of Health grant, to evaluate ATUSA’s diagnostic performance against traditional mammography and MRI. The study will also assess the company’s machine-learning algorithms for identifying and classifying abnormal masses and examine whether the automated approach produces consistent 3D volumes independent of a user’s clinical background. iSono Health said trial sites include UC Davis, Veda Trials (Axia Women’s Health), and City of Hope.
Alongside the commercial launch, iSono Health said it is opening its Series A financing at its inaugural Next Horizon Summit during JPMorgan Healthcare Week as it seeks to accelerate deployments and advance its product roadmap. The company said it has raised $14.7 million to date across rounds, including a $3 million Seed Preferred round in 2025 led by Draper Associates and Transform VC with participation from JSK Venture, GreenSand Equity, and The Josephine Collective. It also reported $3.7 million in non-dilutive funding from NIH, NSF, and NCI. iSono Health said it has secured multiple paying clinics through a Pioneering Partner Program and is scaling an internal team focused on ultrasound and AI.
KEY QUOTES:
“ATUSA is a system-wide upgrade for women’s breast 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.”
“2025 was our inflection point, marking iSono Health’s shift from building to scaling. We’ve created this cutting-edge technology with disciplined capital and relentless execution.”
Neda Razavi, CEO, iSono Health
“What we need are imaging solutions that are easy to use, require minimal training, and can be brought directly into communities. Wearable, operator-independent ultrasound technologies have the potential to dramatically improve access, speed, and accuracy, especially for women with dense breasts.”
Dr. John R. Scheel, M.D., Ph.D., M.P.H., Vice Chair of Global Health, Department of Radiology, Vanderbilt University Medical Center
