iSono Health
AI-powered platform for Accessible and Personalized Breast Health…
- Founded
- 2016
- Status
- Active
- Stage
- Early
- Team size
- 9
- Location
- San Francisco, CA, USA
- Category
- Medical Devices & Diagnostics
- Sector
- Medical Devices
About iSono Health
The iSono Health platform combines automated 3D ultrasound technology with cloud computation and artificial intelligence to empower women and their physicians with early detection and monitoring of breast cancer. Our patented compact ultrasound scanner captures 3D images through automatic scanning of whole breast volume in 1 min. The device connects to a smartphone/tablet/laptop and is controlled by our mobile app. The data is transferred to a secure cloud for image processing and storage. Our machine learning algorithm uses acoustic biomarkers to identify abnormal masses. Our platform’s automated operation and software expands ultrasound use in point-of-care diagnostics as well as monitoring of breast health at home, walk-in and mobile clinics. iSono Health offers women and healthcare providers : Safety: No Radiation Actionable Feedback with AI Fast: 2min Scan Easy to Use
FDA clearances
1 510(k) clearance on record, 2022.
- ATUSA Automated 3D Breast Ultrasound System
K213620
Source: FDA 510(k) database via openFDA.
Clinical trials
1 registered trial with this company as lead sponsor, 2025.
- Status
- Recruiting (1)
- Conditions
- Breast Cancer, Benign Breast Condition, Breast Fibroadenoma, Breast Neoplasms, Breast Disease
Source: ClinicalTrials.gov.
Federal research funding
2 NIH awards totalling $1,999,730, FY2024 to FY2025.
- ATUSA: World's First Wearable and Automated 3D Breast Ultrasound System with AI
Source: NIH RePORTER.
Securities filings
1 Form D filing on record, 2025.
Filed as iSono Health, Inc.
Source: SEC EDGAR. Form D reports an exempt offering; it does not confirm funds raised.
Company data compiled and maintained by Healthcare Discovery.
