Imagio Breast Imaging System
Opto-acoustic/ultrasound breast imaging system for real-time cancer diagnostics
Company profile
Company profile
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
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Embedded · On Premise deployment with recorded integration context.
Company milestones
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
No partners are currently listed.
02 · Flagship portfolio
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Opto-acoustic/ultrasound breast imaging system for real-time cancer diagnostics
Native AI clinical decision support tool for breast cancer diagnostics
03 · Research intelligence
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Research
Journal of biomedical optics · Dec 1, 2019
Optoacoustic imaging of the breast: correlation with histopathology and histopathologic biomarkers.European radiology · Dec 1, 2019
Optoacoustic Imaging and Gray-Scale US Features of Breast Cancers: Correlation with Molecular Subtypes.Radiology · Sep 1, 2019
Clinical optoacoustic imaging combined with ultrasound for coregistered functional and anatomical mapping of breast tumors.Photoacoustics · Dec 1, 2018
Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography.ClinicoEconomics and outcomes research : CEOR · Jan 1, 2018
Exact solution for a photoacoustic wave from a finite-length cylindrical source.The Journal of the Acoustical Society of America · Apr 1, 2015
Clinical validation
No linked records are currently available.
Regulatory
P200003 · Pma · Jan 11, 2021
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Typical breast cancer screening baseline that Imagio aims to reduce
Annual costs of false-positive breast biopsies that can be reduced
From abnormal mass to diagnosis - Imagio provides real-time results
Percentage of women requiring multiple procedures that Imagio can reduce
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
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06 · Company updates
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07 · HAIC coverage
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08 · Official presence
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09 · Market pathway
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Market context
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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