Seno Medical Instruments

What Seno Medical Instruments does

Seno Medical Instruments, Inc. is a privately held medical imaging company founded in 2005 and headquartered in San Antonio, Texas that develops and commercializes opto-acoustic (OA/US) hybrid imaging technology for non-invasive breast cancer diagnosis. Its core product, the Imagio Breast Imaging System, fuses laser-based opto-acoustic imaging with traditional ultrasound and is enhanced by SenoGram, the company's native AI clinical decision-support application that generates real-time probability-of-malignancy scores to help radiologists differentiate benign from malignant lesions. The next-generation Model 9100 received EU MDR CE Mark certification in January 2026, building on an initial CE Mark (April 2014) and U.S. FDA Premarket Approval (January 2021); the company has also secured Vizient GPO contract access (November 2024) and an AMA-issued reimbursement pathway via CPT Code 0857T (effective February 2024).

The company sells Imagio as capital equipment to hospitals, breast-imaging centers, and academic medical centers through a direct enterprise field-sales organization supplemented by a nationwide mobile roadshow demonstration truck and a distributor network in Europe. The primary customer segments are radiologists and breast-imaging specialists (who interpret the studies), hospitals and imaging centers (who procure the equipment and benefit from reduced negative-biopsy rates), and patients with suspicious breast masses (who receive non-invasive imaging without radiation or contrast agents). Revenue is generated through capital-equipment sales, recurring service and support contracts, and procedure-based reimbursement under CPT 0857T, with over $80M raised to date across Series A, C, state grants, and a 2021 round led or participated in by MedCare Investment Funds.

Seno's competitive position rests on a patented OA/US modality with no direct on-market analog, a clinical-evidence base spanning 2,100+ U.S. patients in the PIONEER study and 200 European subjects in MAESTRO, multi-jurisdiction regulatory clearance, and a physician-education platform (Seno University). The business remains in the early phase of U.S. commercialization following the 2022 RSNA launch and a 2023-era commercial-buildout under Chief Revenue Officer Alex Hamlow, with European expansion underway post-EU MDR clearance.

Name

Seno Medical Instruments

Legal name

Seno Medical Instruments, Inc.

Website

https://senomedical.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

51–100 employees

Short description

Seno Medical Instruments is a privately held San Antonio-based medical imaging company that develops and sells the Imagio opto-acoustic/ultrasound breast imaging system, augmented by its native SenoGram AI, to hospitals, imaging centers, and radiologists for non-invasive breast cancer diagnosis.

Ownership category

akta.pro rank

Product category

Breast Cancer Diagnostic Imaging

NAICS

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

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Mammography & Breast Imaging Systems (HLAHABAF)

akta.pro secondary industries

Quality, Peer Review & Compliance Tools (MQSA/ACR/QA) (HLACALAL), Breast Imaging Centers (Mammography/Tomosynthesis) (HLAFAKAD), Imaging & Diagnostic Interoperability (DICOM exchange, image sharing, VNA connectivity) (HLACABAM)

Keywords

• Opto-acoustic imaging
• Breast cancer diagnostics
• Medical imaging equipment
• Ultrasound imaging systems
• AI clinical decision support

Headquarters

HQ city

San Antonio

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, Marketing or Sales, Operations

Revenue model

1. Medical Device Capital Equipment Sales: Sale of Imagio OA/US breast imaging system as capital equipment to hospitals, imaging centers, and healthcare systems. Revenue generated through direct salesforce with multi-year sales cycles involving clinical evaluation, training, and institutional procurement.
2. Service and Support Contracts: Ongoing service, maintenance, and support contracts for installed Imagio systems, providing recurring revenue from existing customer base.
3. Reimbursement (CPT Code 0857T): American Medical Association issued CPT code 0857T enables pathway for reimbursement when using Seno's opto-acoustic technology in breast cancer diagnosis, supporting procedure-based revenue.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels9 records

Core offering

Seno Medical Instruments develops and commercializes the Imagio® Breast Imaging System, a hybrid opto-acoustic/ultrasound (OA/US) platform that fuses laser-light-based functional imaging with traditional ultrasound and the SenoGram® AI decision-support tool to help radiologists differentiate benign from malignant breast lesions non-invasively without radiation, contrast agents, or compression. The company sells this capital imaging equipment and ongoing service contracts to hospitals, imaging centers, and healthcare systems in the United States and Europe.

Product overview

Seno Medical Instruments offers a unified breast imaging portfolio centered on the Imagio® system—a hybrid opto-acoustic/ultrasound (OA/US) imaging platform. The core Imagio® product fuses functional opto-acoustic imaging with anatomical ultrasound, enhanced by the native SenoGram® AI decision support tool for real-time differentiation of benign and malignant breast lesions. The recently launched Model 9100 (2026) represents the next-generation version with EU MDR CE Mark certification. Seno University provides complementary on-demand training for clinical proficiency. The company operates exclusively in medical imaging for breast cancer diagnostics, with no discrete add-on modules or platform extensibility.

Differentiator

Problem solved

Functional benefit

Brands

• Imagio®: The Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate functional and anatomical images of the breast for breast cancer diagnosis.
• SenoGram®
• Seno University
• Seno Cares

Products and services

• Imagio Breast Imaging System The Imagio breast imaging system fuses opto-acoustic imaging technology with traditional ultrasound and the SenoGram AI decision support tool to generate functional and anatomical images of the breast. It helps physicians differentiate between benign and malignant breast lesions non-invasively without radiation, contrast agents, or compression. It is sold as capital equipment to hospitals, imaging centers, and academic medical centers for use by radiologists and breast imaging specialists.
• Imagio Model 9100 Next-generation Imagio system that received EU MDR CE Mark certification in January 2026. It combines opto-acoustic imaging, artificial intelligence (SenoGram), and ultrasound to differentiate between benign and malignant breast lesions non-invasively without radiation, contrast agents, or compression. It is sold to hospitals and imaging centers in the European market.

Quantifiable outcome

• 43% reduction in negative biopsies achievable with OA/US imaging vs. standard ultrasound
• +5 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• VizientcoreChannel Partner/ Reseller/ Distributor · 24 November 2024Seno Medical received Innovative Technology Contract from Vizient for its Imagio Breast Imaging System in November 2024. The contract was awarded for products that bring improvement to the healthcare industry, providing GPO pricing pathway for Vizient member hospitals and health systems to access the technology.
• University of Texas Medical BranchminorStrategic or Co-development Partner · 21 August 2007Collaborating research institution for development of opto-acoustic technology proof-of-concept in partnership with Fairway Medical Technologies.
• Fairway Medical TechnologiescoreStrategic or Co-development Partner · 28 June 2006Development partner for patented laser opto-acoustic breast imaging technology. Fairway Medical Technologies collaborated with University of Texas Medical Branch in Galveston to develop proof-of-concept. NCI awarded Fairway Medical a $1.1M grant to expand technology for prostate cancer applications.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Hologic: Hologic is the dominant U.S. women's-health company and the largest dedicated breast-imaging franchise (3D mammography, Genius, Affirm). Seno competes for the same radiology-budget dollars and the same radiologist/breast-imaging-specialist end users; Hologic is also a direct talent source for Seno (CEO Tom Umbel spent 15 years there).
• Philips: Philips is a major mammography, ultrasound, and interventional imaging vendor and competes broadly in hospital breast-imaging capital purchases alongside Seno's target customers.
• Siemens Healthineers: Siemens Healthineers is a major mammography and ultrasound vendor (MAMMOMAT, ACUSON) and competes in the same breast-diagnostic imaging market as Seno, targeting the same hospitals and radiology departments across the U.S. and Europe.
• GE HealthCare: GE HealthCare is one of the largest players in mammography, ultrasound, and breast-imaging AI, with its Breast Imaging business previously led by Seno's SVP of Sales & Marketing. It competes for the same hospital capital-budget dollars and radiologist workflows.

Direct peers

• FUJIFILM SonoSite: FUJIFILM SonoSite is a leading point-of-care and traditional ultrasound manufacturer — the closest direct peer to the ultrasound half of Seno's hybrid OA/US system. Seno's SVP of Engineering previously led product realization at SonoSite, indicating close technical and competitive overlap.
• Delphinus Medical Technologies: Delphinus developed the SoftVue whole-breast ultrasound tomography system for breast-cancer screening and diagnostics. It is one of the few companies pursuing novel functional breast-imaging modalities analogous to Seno's opto-acoustic approach.
• iCAD: iCAD provides AI-based breast-cancer detection and decision-support (ProFound AI for DBT) deployed on incumbent mammography systems. It is a direct competitor for the AI clinical decision-support portion of Seno's value proposition — SenoGram vs. ProFound AI.

Emerging players

• Dilon Technologies: Dilon Technologies manufactures molecular breast imaging and other dedicated breast-imaging systems aimed at reducing benign biopsies — directly addressing the same $2.18B false-positive biopsy problem Seno's technology targets.
• Real Imaging: Real Imaging developed novel functional breast-imaging modalities (signature mapping) used as an adjunct to mammography for lesion classification — a direct emerging competitor in the breast-imaging diagnostic adjunct market.
• Volpara Health: Volpara provides AI-driven breast-imaging analytics, density assessment, and reporting used by breast imaging centers. It competes with SenoGram at the AI decision-support layer and addresses radiologist productivity/quality in the same clinical workflow.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/senomedical
• YouTubevimeo.com/senomedical
• Facebookfacebook.com/senomedicalinstruments
• LinkedInlinkedin.com/company/seno-medical-instruments
• Instagraminstagram.com/senomedical

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds6 records

Investors1 record

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 Seno Medical Instruments