Isis Medical Inc.

What Isis Medical Inc. does

Isis Medical Inc., doing business as iVu Imaging Corporation, is a Texas-incorporated, privately-held medical device company that develops and commercializes the SOFIA automated 3D breast ultrasound (ABUS) system. The company is headquartered in Southlake, Texas, with approximately 25 employees, and positions SOFIA as a supplemental imaging modality for the roughly 40% of women with dense breast tissue whose cancers are frequently masked on mammograms. Its product platform is built on automated whole-breast ultrasound scanning with a 200mm field of view, a 30-second acquisition time, multi-planar 3D reconstruction, DICOM-compatible data sets, and a compression- and radiation-free patient experience using sound-wave imaging.

The company's commercial portfolio comprises two product variants on a shared underlying technology: the core SOFIA 3D Breast Ultrasound system targeted at radiology practices and imaging centers for high-volume interpretation, and SOFIA MS, a variant specifically configured for in-office deployment in OB/GYN and primary care practices. SOFIA MS is sold as a turnkey installation that requires no room modifications and can be operated by existing clinical staff (mammographers/sonographers), enabling same-visit supplemental screening. The system is FDA cleared, and per company materials over 35 U.S. states have enacted legislation related to healthcare coverage for SOFIA-based breast ultrasound exams, with some states eliminating copays and deductibles for patients.

iVu Imaging generates revenue through direct B2B sales of hardware systems to healthcare facilities, including OB/GYN practices, primary care practices, radiology/imaging centers, and hospitals. Pricing is quote-based and not publicly disclosed; most facilities schedule SOFIA exams in 15–20 minute appointment slots. Distribution is direct enterprise field sales with no third-party reseller model indicated, and the company claims a global footprint spanning North America, Europe, Asia, South America, and Australia. The company has not disclosed institutional funding, leadership team details, or financial results in the available sources.

Name

Isis Medical Inc.

Legal name

iVu Imaging Corporation

Website

https://ivuimaging.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

Isis Medical Inc. (iVu Imaging Corporation) is a Texas-based medical device company that sells the FDA-cleared SOFIA automated 3D breast ultrasound system for supplemental breast cancer screening in dense-breast patients to OB/GYN, primary care, and radiology providers worldwide.

Ownership category

akta.pro rank

Product category

Medical Imaging Equipment

NAICS

Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Mammography & Breast Imaging Systems (HLAHABAF)

akta.pro secondary industry

Ultrasound & Echography Systems (HLAHABAD)

Keywords

• Automated breast ultrasound
• Medical imaging equipment
• 3D breast ultrasound
• Dense breast screening
• Diagnostic imaging devices

Headquarters

HQ city

Southlake

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Imaging Equipment Sales: Sale of SOFIA 3D Breast Ultrasound systems to healthcare facilities including OB/GYN practices, primary care practices, imaging centers, and hospitals. Equipment is installed in existing exam rooms without modifications.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Isis Medical Inc. (operating as iVu Imaging Corporation / iVu) develops and manufactures the SOFIA 3D Automated Breast Ultrasound (ABUS) system, a medical imaging device used by OB/GYN practices, primary care clinics, radiology and imaging centers, and hospitals as a supplemental screening tool for patients with dense breast tissue where mammography alone has reduced sensitivity. The company also offers the SOFIA MS system within the same product line.

Product overview

Isis Medical Inc. (iVu Imaging Corporation) offers a unified product portfolio centered on the SOFIA platform for automated 3D breast ultrasound imaging. The core offering is the SOFIA 3D Breast Ultrasound system, designed for rapid, comfortable, and accurate breast cancer screening in dense breast patients. SOFIA MS extends this technology specifically for OB/GYN and primary care practices as an in-office solution. Both products share the same underlying technology: automated 3D ultrasound scanning, multi-planar reconstruction, and DICOM-compatible review interfaces. The company positions SOFIA as a supplemental screening tool to mammography for women with dense breast tissue, offering compression-free, radiation-free imaging that can double early cancer detection rates.

Differentiator

Problem solved

Functional benefit

Brands

• SOFIA: Automated 3D Breast Ultrasound system for breast cancer imaging, particularly designed for dense breast patients. Provides rapid 30-second full breast scans with 3D imaging capability.
• SOFIA MS

Products and services

• SOFIA 3D Breast Ultrasound
• SOFIA MS

Quantifiable outcome

• Doubles early cancer detection rates for dense breast patients
• +5 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators1 record

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Hologic: Leader in breast imaging (3D mammography / Genius) with a historical presence in automated breast ultrasound via the Multicare Platinum and successor products. Comparable as a major women's-health imaging incumbent with breast cancer screening workflows spanning mammography and adjunct ultrasound.
• GE HealthCare: Global imaging incumbent with the Invenia Automated Breast Ultrasound (ABUS) system, the established direct competitor to SOFIA in 3D whole-breast ultrasound. Comparable because it targets the same dense-breast supplemental screening use case with similar automated ultrasound technology, though distributed through a much broader imaging portfolio.
• Siemens Healthineers: Manufactures the ACUSON breast ultrasound line (e.g., ACUSON Sequoia and ACUSON S family) used for breast imaging, including advanced shear-wave and ABUS-adjacent workflows. Comparable as a large medtech imaging peer with overlapping ultrasound breast imaging capabilities and hospital-channel reach.
• Philips Healthcare: Markets premium ultrasound platforms (e.g., EPIQ, Affiniti) commonly used for breast imaging, including automated breast volume scanning workflows. Comparable as a global imaging incumbent whose breast ultrasound offering overlaps with SOFIA's clinical category, though broader in scope.
• Canon Medical Systems: Provides Aplio i-series ultrasound systems widely used for breast imaging in radiology departments. Comparable as a major imaging equipment manufacturer with overlapping breast ultrasound capability and similar hospital and imaging-center GTM.

Emerging players

• SuperSonic Imagine (Hologic): Developer of the Aixplorer ultrasound platform with shear-wave elastography frequently used in breast lesion characterization, now under Hologic ownership. Comparable as a breast-ultrasound technology peer with focus on adjunct diagnostic value to mammography, similar to SOFIA's positioning.
• iCAD Inc. Provides AI-powered breast health software (e.g., ProFound AI for DBT) used in mammography and breast imaging workflows. Comparable as an adjacent breast-imaging software/diagnostics vendor increasingly integrated with breast ultrasound workflows to flag and characterize dense-breast findings.
• Volpara Health: Specializes in breast density assessment and personalized breast cancer screening software used to identify patients who benefit from supplemental ultrasound. Comparable as an emerging participant in the dense-breast screening ecosystem whose software directs downstream demand for products like SOFIA.

Regional players

• Mindray Bio-Medical: Large China-based ultrasound manufacturer with breast imaging offerings that compete in global tenders and value-oriented markets. Comparable as a value-segment ultrasound peer whose pricing pressure could affect SOFIA's expansion in cost-sensitive geographies outside the U.S.

Direct peers

• Delphinus Medical Technologies: Maker of SoftVue, a 3D whole-breast ultrasound system designed as a supplemental screening modality for dense breast tissue and competing directly with SOFIA. Comparable as an emerging ABUS-class rival targeting identical patient segments, radiology workflow integration, and dense-breast screening economics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/isis-medical-inc.

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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 Isis Medical Inc.