iSono Health

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.

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

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

• Breast ultrasound imaging
• AI medical imaging
• 3D ultrasound scanner
• Portable diagnostic devices
• Breast cancer screening

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations

Revenue model

1. 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.
2. Software/SaaS Services: Secure web application for remote viewing with advanced 3D visualization, likely sold as subscription for cloud access and software updates.
3. Professional Services - Training: Initial live demo/training sessions and comprehensive instructional videos provided with system purchase.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core 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

Named customers1 record

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature7 records

Partnerships

One partnership is on record.

• ArionkodercoreTechnology or Integration · 19 February 2026Arionkoder, 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

Broad 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

• Xx.com/isonohealth
• YouTubeyoutube.com/channel/UC4ZoH6M1YzuHN4hLzemMe8w
• LinkedInlinkedin.com/company/6453013

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds6 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about iSono Health