Company profile

Seno Medical Instruments

Medical Imaging & Radiology

Company profile

About Seno Medical Instruments

Seno Medical Instruments is a medical imaging company that has developed the Imagio® Breast Imaging System, an innovative diagnostic platform that fuses opto-acoustic technology with gray-scale ultrasound to improve breast cancer detection and diagnosis. The company's flagship product addresses inefficiencies in the current breast cancer diagnostic pathway, which often results in multiple procedures, inconclusive results, and negative patient experiences. The Imagio® system uses laser light transmitted through suspicious breast tissue to generate ultrasound signals that display both functional and anatomical information about relative blood and oxygen concentration. This enables clinicians to differentiate between malignant and benign tissue in real-time with a single exam. The system is enhanced by SenoGram®, a native AI-based clinical decision support tool that assists radiologists in making more accurate diagnoses at the point of care. Seno Medical holds the core patent on opto-acoustic technology for medical applications and has developed a robust intellectual property portfolio. The company's technology aims to reduce the 71% false-positive biopsy rate, decrease the median 48-day wait time from abnormal mass detection to diagnosis, and eliminate unnecessary procedures. The Imagio® system has received FDA PMA approval in the United States and serves radiologists, healthcare systems, and patients by providing earlier diagnosis of malignancy, reducing patient stress and wait times, and improving practice efficiency. Beyond breast cancer, the company envisions future applications in thyroid, head and neck, prostate, cervical, ovarian, and bladder cancers, as well as therapeutic drug monitoring.

Company description Seno Medical Instruments official website

Primary marketMedical Imaging & Radiology
Commercial modelCommercial information available on request
Company presenceLinkedIn X
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01 · Operating footprint

Where the Company operates

Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.

Clinical focus

  • Breast cancer
  • Breast masses
  • Fibroadenomas
  • Fibrocystic conditions
  • Invasive breast carcinoma
  • Invasive ductal carcinoma
  • Luminal A cancer
  • Luminal B cancer
  • Triple negative breast cancer

Who it serves

  • Breast imaging centers
  • Diagnostic imaging facilities
  • Healthcare systems
  • Hospitals
  • Radiologists

Deployment & integration

Embedded · On Premise deployment with recorded integration context.

Geographic context

MarketsCanada · Europe · United States
Company sourceOfficial website

Company milestones

Platform expansion

FDA PMA approval achieved for Imagio® Breast Imaging System (Model 9100). Nationwide roadshow bringing demonstrations to facilities. CE mark application pending under MDR in Europe.

Partnerships

Recorded partners

No partners are currently listed.

02 · Flagship portfolio

Products, workflows, and platform capabilities

Selected source-backed Company products and the available commercial context.

Imagio Breast Imaging System

Opto-acoustic/ultrasound breast imaging system for real-time cancer diagnostics

Device · On PremiseCompany source

SenoGram

Native AI clinical decision support tool for breast cancer diagnostics

Software · EmbeddedCompany source

03 · Research intelligence

Research Intelligence evidence

Publications, preprints, clinical validation, and regulatory records in Evidence Position order.

04 · Company-reported outcomes

Outcomes and case studies

Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.

71% false-positive breast biopsies

Typical breast cancer screening baseline that Imagio aims to reduce

$2.18 billion annual costs

Annual costs of false-positive breast biopsies that can be reduced

48 days median wait time

From abnormal mass to diagnosis - Imagio provides real-time results

20.1% requiring 3+ procedures

Percentage of women requiring multiple procedures that Imagio can reduce

other

Reducing false-positive breast biopsies and improving diagnostic confidence

71.0% of breast biopsies are false-positive, costing $2.18 billion annually; Imagio aims to reduce these unnecessary biopsies

05 · Leadership

Leadership team

Leadership profiles and professional links from the current Company record.

No active leadership profiles are currently listed.

06 · Company updates

Updates from Seno Medical Instruments

Recent articles published on Seno Medical Instruments's official website.

No Company updates are currently listed.

07 · HAIC coverage

Coverage and analysis

Health AI Central reporting that mentions this Company.

No HAIC coverage is currently linked to this Company.

08 · Official presence

Company sources and channels

Curated official destinations from the active Company record.

09 · Market pathway

Additional Companies in this Market

Other active Companies in the same market, selected alphabetically from the HAIC directory.

Market context

Medical Imaging & Radiology

Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.

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ResearchEvidence analysis

Linked research, clinical, and regulatory source pathways.

CompanyTechnical context

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MethodSource & review record

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