iSono Health
iSono Health develops ATUSA, an FDA-cleared portable, automated 3D breast ultrasound scanner with AI-driven acoustic biomarker analysis that delivers whole-breast imaging in two minutes for physician offices, women's health clinics, and high-risk patients.
- Company typePrivate
- Founded2014
- HeadquartersSan Francisco, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What iSono Health does
iSono Health is a US-based, venture-backed medical device company founded in 2014 and headquartered in Sunnyvale, California, that has developed ATUSA, an FDA 510(k)-cleared, AI-driven portable and automated 3D breast ultrasound scanner. The company's primary customers are physician offices and women's health clinics seeking fast, convenient whole-breast imaging at the point of care, with secondary persona targets including women with dense breast tissue and high-risk individuals who require regular, longitudinal monitoring. ATUSA is designed to be operator-agnostic, allowing physicians, nurses, and medical assistants to perform scans without specialized ultrasound training.
The ATUSA platform combines a 3D ultrasound scanner with a wearable accessory and a proprietary scan method to capture full breast volumes in approximately two minutes per breast, which the company states is 10–15 times faster than manual sonographer probing. The system includes a Windows application for real-time 2D image display, review, and measurement, and a HIPAA-compliant secure web application for remote viewing and longitudinal patient monitoring. Machine learning algorithms using acoustic biomarkers adapt imaging to patient anatomy, and a collaboration with AI consultancy Arionkoder demonstrated a 28.7% reduction in false detections; however, the company explicitly states that AI features remain in the research phase and are not part of the cleared clinical claims.
iSono Health generates revenue through direct hardware sales of the ATUSA scanner and likely recurring software/cloud subscription revenue for the remote viewing application, supplemented by initial training services. Pricing is quote-based and not publicly disclosed, with sales conducted via "Schedule a Demo" and "Contact Us" forms targeting enterprise healthcare providers. ATUSA was commercially launched in January 2026 after receiving FDA 510(k) clearance in 2022. The company has raised $14.7M cumulatively in venture and SBIR funding, opened a Series A round at the Next Horizon Summit during JPMorgan Healthcare Week, and added strategic backing from Czech-based JSK Investments in October 2025 to support global expansion.
iSono Health firmographics
Firmographics- Name
- iSono Health
- Legal name
- iSono Health
- Website
- https://isonohealth.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- iSono Health develops ATUSA, an FDA-cleared portable, automated 3D breast ultrasound scanner with AI-driven acoustic biomarker analysis that delivers whole-breast imaging in two minutes for physician offices, women's health clinics, and high-risk patients.
- Ownership category
- akta.pro rank
iSono Health industry classification
Industry- Product category
- Medical Imaging Devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Mammography & Breast Imaging Systems (HLAHABAF)
- akta.pro secondary industries
- Ultrasound & Echography Systems (HLAHABAD), Medical Imaging AI (HDAAAEAH)
Keywords
Where iSono Health is headquartered
LocationHeadquarters
- HQ city
- San Francisco
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
iSono Health business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations
Revenue model
- Hardware Sales - ATUSA Scanner: Sale of the ATUSA 3D ultrasound scanner system including hardware components (scanner, wearable accessory) and Windows application software for image display, review and measurement.
- Software/SaaS Services: Secure web application for remote viewing with advanced 3D visualization, likely sold as subscription for cloud access and software updates.
- Professional Services - Training: Initial live demo/training sessions and comprehensive instructional videos provided with system purchase.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | ATUSA System - Enterprise medical device pricing |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels6 records
iSono Health product offering
Product offeringCore offering
iSono Health develops and sells ATUSA, the world's first FDA 510(k)-cleared AI-driven portable and automated 3D breast ultrasound scanner. The system captures full breast volumes in approximately two minutes per breast without requiring a trained ultrasound operator, and includes a wearable accessory, Windows application for real-time 2D imaging, and a HIPAA-compliant secure web application for remote viewing with advanced 3D visualization.
Product overview
iSono Health offers ATUSA, a unified platform combining hardware (3D ultrasound scanner and wearable accessory) with integrated software. The system includes a Windows application for real-time 2D image visualization, advanced 3D visualization with lesion localization in multiple views, and a secure web application for cloud-based remote viewing and longitudinal patient monitoring. The platform's AI algorithms analyze ultrasound images and adjust to patient anatomy using acoustic biomarkers to improve detection accuracy.
Differentiator
Problem solved
Functional benefit
Brands
- ATUSA: World's first AI-driven portable and automated 3D breast ultrasound scanner - FDA 510(k) cleared wearable system for breast imaging at point of care
Products and services
- ATUSA System The ATUSA System is a comprehensive breast imaging solution aimed at physician offices and women's health clinics for fast and convenient whole breast imaging at the point of care. It consists of a 3D ultrasound scanner, a wearable accessory, a Windows application (desktop and tablet, Windows 7 and higher) for real-time image display, review and measurement, and a secure web application for remote viewing with advanced 3D visualization. The system is fully automated, operator-agnostic, and FDA 510(k) cleared.
Quantifiable outcome
- 28.7% reduction in false detections in breast cancer scanning
- +2 more outcomes
Companies that use iSono Health
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles1 record
iSono Health technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature7 records
iSono Health partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- ArionkodercoreArionkoder, an AI consulting firm, collaborated with iSono Health on AI development, achieving a 28.7% reduction in false detections in breast cancer scanning through machine learning improvements using acoustic biomarkers.
Scale indicators7 records
Recent moves6 records
Expansion highlights5 records
iSono Health competitors and assessment
Company assessmentBroad incumbents
- Hologic: Dominant incumbent in mammography and breast health with the largest installed base of 3D mammography systems. Directly competes with iSono in the breast imaging diagnostic workflow and has vastly greater commercial and clinical evidence resources.
- GE HealthCare: Global incumbent in ultrasound and breast imaging with Invenia ABUS automated breast ultrasound system. Competes with iSono in supplemental breast ultrasound but as part of a broad imaging portfolio rather than a dedicated point-of-care solution.
- Siemens Healthineers: Major incumbent in breast imaging with mammography, ultrasound, and AI imaging offerings. Competes in the same clinical workflows as iSono with established hospital sales channels and global reach.
Direct peers
- Butterfly Network: Maker of handheld portable ultrasound probes connected to smartphones, with AI-assisted imaging tools. Closest direct competitor to iSono in portable point-of-care ultrasound with AI, though focused on whole-body imaging rather than automated dedicated breast scanning.
- Delphinus Medical Technologies: Developer of SoftVue, a whole breast ultrasound tomography system for dense breast tissue supplemental imaging. Most direct competitor in automated whole breast ultrasound, though iSono differentiates on portability and point-of-care deployment.
- QT Ultrasound: Developer of radiation-free, automated transmission ultrasound for breast imaging. Direct competitor in automated no-radiation breast imaging, targeting similar supplemental screening use cases for women with dense breast tissue.
- Koning Health: Manufacturer of dedicated breast CT systems for 3D imaging without compression. Competes in the non-mammography dedicated breast imaging space targeting similar physician office and women's health clinic deployments.
Emerging players
- iCAD Inc. AI-focused breast imaging company offering ProFound AI for mammography and DBT. Comparable as a software-and-AI layer on top of breast imaging hardware, targeting the same clinical decision-support workflows iSono aims to enable.
- Volpara Health: Breast density analytics and risk assessment software company serving mammography providers. Comparable as a women's health AI/analytics platform addressing dense breast imaging decisions iSono targets with its ATUSA system.
- Whiterabbit AI: AI company applying machine learning to mammography and breast cancer risk prediction. Comparable as an emerging AI-focused women's health imaging peer pursuing clinical workflow integration with breast imaging providers.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
iSono Health social profiles
Digital presenceiSono Health compliance and trust
Trust signalCompliance1 record
iSono Health financial estimates
Financial estimateRevenue estimate
Valuation estimate
iSono Health leadership team
Management profileNumber of profiles
Profiles8 records
iSono Health funding detail
Funding detailFunding overview
Funding rounds6 records
Investors8 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
iSono Health M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about iSono Health
What does iSono Health do?
iSono Health develops and sells ATUSA, the world's first FDA 510(k)-cleared AI-driven portable and automated 3D breast ultrasound scanner. The system captures full breast volumes in approximately two minutes per breast without requiring a trained ultrasound operator, and includes a wearable accessory, Windows application for real-time 2D imaging, and a HIPAA-compliant secure web application for remote viewing with advanced 3D visualization.
Is iSono Health a public or private company?
iSono Health is a private company. It is classified as venture growth investor backed and is currently operating.
When was iSono Health founded?
iSono Health was founded in 2014. It employs 1 to 10 people.
Where is iSono Health based?
iSono Health is headquartered in San Francisco, United States, in the North America region.
How does iSono Health make money?
Three revenue lines are on record. Hardware Sales - ATUSA Scanner is the primary driver. The others are software/SaaS Services and professional Services - Training.
Who are iSono Health's main competitors?
Broad incumbents on record are Hologic, GE HealthCare and Siemens Healthineers. Direct peers are Butterfly Network, Delphinus Medical Technologies, QT Ultrasound and Koning Health. Emerging players are iCAD Inc., Volpara Health and Whiterabbit AI.
Does iSono Health have an API?
No public API is recorded for iSono Health.
What industry is iSono Health in?
iSono Health's product category is Medical Imaging Devices. Its primary akta.pro industry code is HLAHABAF, Mammography & Breast Imaging Systems, with a secondary code of HLAHABAD, Ultrasound & Echography Systems. Its NAICS code is 334510 and its SIC code is 3841.