Breast ultrasound technology developer iSono Health has launched its wearable, portable 3D breast ultrasound system, ATUSA.
Designed for point-of-care imaging, the system provides an "ultrasound-as-a-service" model that combines wearable and automated hardware, cloud-based AI, and consumables, according to the firm.
ATUSA received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2022 and is not intended to be used as a replacement for screening mammography. However, the ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) study will evaluate the diagnostic performance of the platform compared to traditional mammography and MRI, the company noted. The study is being conducted at University of California, Davis (UC Davis), Veda Trials (Axia Women’s Health), and the City of Hope.
Coinciding with the product launch, iSono announced the opening of its Series A financing to accelerate global deployments and advance its AI-driven "sentient partner" roadmap toward "machine-as-the-expert breast imaging robotics."
iSono Health has raised $14.7 million, including a new $3 million Seed Preferred round in 2025, led by Draper Associates and Transform VC, with support from JSK Venture, GreenSand Equity, and The Josephine Collective, the firm highlighted.
