Products

Imagio Breast Imaging System
Seno Medical Instruments
Oncology AI
The Imagio® Breast Imaging System is a non-invasive diagnostic tool that looks and feels like a traditional ultrasound. It can be completed quickly after a mammogram to diagnose or rule out breast cancer in abnormal tissue—providing faster answers to patients and diagnostic confidence to clinicians.

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About Seno Medical Instruments

Seno Medical Instruments is a medical imaging company focused on commercializing opto-acoustic (photoacoustic) imaging, a novel modality for cancer diagnosis. Their flagship product, the Imagio® Breast Imaging System, integrates opto-acoustic technology with conventional ultrasound to provide real-time functional and anatomical images of the breast. This system aims to enhance diagnostic confidence by detecting angiogenesis (new blood vessel growth) and deoxygenation, which are key physiological indicators of malignancy, thereby potentially reducing the rate of unnecessary breast biopsies.

The Imagio® system, which received FDA PMA approval in 2021 (with supplemental approval in 2022) and CE Mark certification under MDR in January 2026, offers a non-invasive approach that does not expose patients to ionizing radiation or contrast agents. It also incorporates AI-based decision support (SenoGram®) to further assist clinicians in differentiating between benign and malignant breast lesions. Beyond breast cancer, Seno Medical’s patented platform technology holds potential for future applications in the early detection and diagnosis of other cancers, including melanoma, thyroid, prostate, colon, head and neck, cervical, ovarian, and bladder cancer, as well as for therapeutic monitoring.

Focus Areas

Opto-acoustic imaging breast cancer diagnosis functional imaging angiogenesis deoxygenation AI-based decision support melanoma thyroid cancer prostate cancer colon cancer

Business Intelligence

Key InvestorsMedCare Investment Funds, Texas Emerging Technology Fund, WP Global Partners
PartnershipsVisualSonics (2008), University of Prince Edward Island (2008), Ryerson University of Toronto (2008), Vizient (November 2024), IHE SHARAZONE (May 2024), Pinnacle Health Group (February 2024)
AcquisitionsAcquired early opto-acoustic technology and working pre-prototypes from Dr. Alexander Oraevsky and Fairway Medical Technologies in exchange for stock (2005)
TechnologyOpto-acoustic imaging (photoacoustic imaging or PAI) fused with ultrasound (OA/US), laser and acoustics integration, functional imaging, AI-based decision support (SenoGram®)
FDA Clearances2 cleared products (estimated)

What Physicians Need to Know

Core Imaging Modality
Pioneering Opto-Acoustic (OA/US) imaging, which fuses laser light and ultrasound to provide both functional and anatomical information about tissue.
Primary Application
Specializes in breast cancer diagnosis with its FDA-approved Imagiou00ae Breast Imaging System, designed to differentiate benign from malignant masses.
Functional Imaging Focus
Unlike traditional anatomical imaging (X-ray, ultrasound), Seno's technology produces high-resolution images based on tissue performance, specifically hemoglobin concentration and oxygenation levels.
Cancer Biomarkers
Detects key indicators of malignancy such as angiogenesis (growth of new blood vessels) and deoxygenation (reduced oxygen content in blood around tumors).
AI-Based Decision Support
Integrates SenoGramu00ae, a native, purpose-built AI clinical decision support tool, to enhance diagnostic accuracy and assist in assigning BI-RADS categories.
Future Applications
The underlying opto-acoustic platform technology has potential follow-on applications for the early detection of other cancers, including melanoma, thyroid, prostate, and colon cancer.
Physician Tip

Seno Medical Instruments' Imagiou00ae system offers a significant advancement for physicians by providing real-time, functional diagnostic imaging that can increase diagnostic confidence and reduce unnecessary biopsies. The fusion of opto-acoustics with ultrasound, coupled with AI-driven decision support (SenoGramu00ae), allows for a more precise differentiation between benign and malignant breast tissue without ionizing radiation, injected contrast agents, or compression. This leads to a simplified diagnostic pathway, faster answers for patients, and improved workflow efficiency for practices. The ability to visualize angiogenesis and deoxygenation provides critical functional information that traditional anatomical imaging modalities cannot. Furthermore, clinical data suggests the system may help differentiate prognostic subtypes of breast cancer, potentially aiding in tailored treatment regimens.

The Imagiou00ae Breast Imaging System is a hybrid modality device that concurrently collects opto-acoustic images in conjunction with diagnostic gray-scale (B-mode) ultrasound. Its native AI clinical decision support tool, SenoGramu00ae, is purpose-built to work seamlessly with the system, providing integrated diagnostic assistance. While specific integrations with broader PACS or EMR systems are not detailed, the system's ability to provide real-time functional and anatomical images, along with AI-driven insights, suggests a design aimed at streamlining the diagnostic workflow within existing clinical environments.

Products by Seno Medical Instruments

1 product in the directory

Imagio Breast Imaging System
Seno Medical Instruments
Oncology AI
The Imagio® Breast Imaging System is a non-invasive diagnostic tool that looks and feels like a traditional ultrasound. It can be completed quickly after a mammogram to diagnose or rule out breast cancer in abnormal tissue—providing faster answers to patients and diagnostic confidence to clinicians.

What the Web Says

Seno Medical Instruments, Inc. is a medical device company focused on developing opto-acoustic technology for breast cancer diagnosis. While specific product reviews are limited on major platforms, employer reviews on Glassdoor indicate a generally positive work environment with some common challenges seen in smaller companies. The company's technology, Imagiou00ae, has received FDA approval and is designed to improve diagnostic accuracy.

Overall: Mixed

Strengths

  • Innovative technology (Imagiou00ae) for breast cancer detection
  • Positive impact on patient care
  • Good work-life balance reported by some employees
  • Supportive colleagues and management in many instances
  • Opportunity to work with cutting-edge medical technology
  • FDA approval for their key product

Limitations

  • Limited public product reviews on major platforms (G2, Capterra)
  • Compensation can be a concern for some employees
  • Challenges with company growth and scaling processes
  • Potential for long hours in certain roles
  • Communication issues reported by a minority of employees
  • Small company environment may not suit everyone

Based on reviews from: Glassdoor, Seno Medical Website, Healthcare IT News/Press Releases (regarding FDA approval)

Last updated: 2026-07-19

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Frequently Asked Questions

Seno Medical's Imagiou00ae Breast Imaging System utilizes opto-acoustic (OA) technology fused with conventional ultrasound to provide both functional and anatomical information about breast lesions. This unique approach detects increased hemoglobin concentration and deoxygenation, which are key indicators of angiogenesis associated with malignant tumors, offering enhanced diagnostic confidence.
The Imagiou00ae System integrates SenoGramu00ae, a native AI clinical decision support tool, to assist radiologists in classifying breast lesions according to BI-RADS. This AI enhancement aims to improve diagnostic accuracy and reduce the rate of false-positive biopsies.
The Imagiou00ae Breast Imaging System (Model 9100) received Premarket Approval (PMA) from the U.S. FDA in January 2021, with a supplemental PMA approval in June 2022. For Europe, the current Model 9100 is pending CE mark under MDR, though a previous version had received CE Mark.
While the Imagiou00ae System is currently approved for breast cancer diagnosis, Seno Medical views its opto-acoustic platform as having potential for future applications in other cancers. These could include thyroid, head and neck, prostate, cervical, ovarian, and bladder cancers, with feasibility studies having been conducted for thyroid abnormalities.
Direct pricing for the Imagiou00ae System is not publicly disclosed and typically requires a direct inquiry or demo request from Seno Medical. The company offers support through its representatives and has partnered with Cogmedix for manufacturing and commercialization.
Founded in 2005, Seno Medical has raised $72 million in funding and is led by an experienced management team and board with extensive medical device commercialization expertise. They hold an Innovative Technology contract with Vizient, Inc., a major healthcare performance improvement company, and partner with Cogmedix for manufacturing.

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