Imagio Breast Imaging System

by Seno Medical Instruments  · Based in United States → — Shining a new light on breast cancer diagnostics with AI-powered opto-acoustic ultrasound.
General Surgery Oncology Radiology
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Overview

The Imagio® Breast Imaging System by Seno Medical Instruments is an innovative medical imaging modality that combines laser light and conventional ultrasound technology (Opto-Acoustic/Ultrasound or OA/US) to provide real-time functional and anatomical images of the breast. This system is designed to aid clinicians in differentiating between malignant and benign breast tissue by revealing information about blood and oxygen concentration, which are key indicators of cancer. It integrates an AI-driven clinical decision support tool called SenoGram®, which assists radiologists in objectively assigning BI-RADS classifications and assessing the likelihood of malignancy (LOM). The Imagio system aims to increase diagnostic confidence, reduce the number of unnecessary biopsies, and streamline the breast cancer diagnostic pathway without using ionizing radiation or contrast agents.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Opto-Acoustic/Ultrasound (OA/US) technology for fused functional and anatomical imaging
  • AI-driven clinical decision support tool (SenoGramu00ae) for objective BI-RADS classification and LOM assessment
  • Real-time imaging to differentiate malignant and benign breast tissue
  • Non-invasive, no ionizing radiation, and no contrast agents
  • Designed to reduce unnecessary breast biopsies and diagnostic workups
  • Provides information on blood oxygenation and vascularity within breast masses
  • Suitable for assessment of BI-RADS 3, 4a, and 4b masses
  • Demonstrated improved specificity without significant loss of sensitivity
  • Capable of differentiating masses as small as 3.5 mm
  • Enhances diagnostic confidence for clinicians at the point of care

Use Cases

  • Diagnostic evaluation of palpable and non-palpable breast lesions
  • Reducing false positive breast biopsies
  • Assessing and refining BI-RADS classifications
  • Adjunctive imaging for suspicious areas identified by mammography or ultrasound
  • Differentiating benign from malignant breast tissue without invasive procedures
  • Improving diagnostic confidence and efficiency in breast cancer care pathways

What Physicians Need to Know

Key Capabilities
Combines optoacoustic (laser light and sound) and conventional ultrasound (OA/US) to provide real-time fused functional and anatomical images of breast tissue. It offers functional information such as vascularity and oxygenation, aiding in the differentiation of malignant from benign masses. The system includes an AI-driven software, SenoGramu00ae, for decision support in BI-RADS classifications and Likelihood of Malignancy (LOM) assessment. It is non-invasive, uses no ionizing radiation or contrast agents, and does not require mammography-like compression.
Clinical Utility
Primarily used as an adjunct to mammography and ultrasound for diagnostic evaluation of breast lesions, especially for BI-RADS 3-5 masses. It enhances diagnostic confidence, reduces false-positive biopsies, and can lead to downgrading of BI-RADS 3, 4a, and 4b masses, potentially reducing the need for invasive procedures or short-interval follow-up. The system aims to provide faster, same-day answers, improving patient experience and workflow efficiency.
Integration Options
Designed to integrate into existing diagnostic workflows, similar to how tomosynthesis was introduced. The system is presented as a complex medical cart, with design considerations for usability, including cable management, console height, monitor range of motion, and cart mobility.
Compliance Status
Received U.S. FDA Premarket Approval (PMA P200003) in January 2021, with supplemental PMA approval in June 2022 for an advanced ultrasound technology model (9100). An earlier model (9005) received CE Mark in Europe in April 2014, while the current Model 9100 is pending CE Mark under MDR. It also received an Innovative Technology contract from Vizient, Inc. in November 2024.
User Experience
Offers a non-invasive scan that resembles a traditional ultrasound, aiming to provide a more comfortable patient experience without the need for needles, dyes, or X-rays. The AI-driven SenoGramu00ae tool assists radiologists in objectively assigning BI-RADS classifications and LOM, enhancing diagnostic confidence and efficiency.
Support Quality
Seno Medical provides on-site training by a Clinical Applications Specialist. All service work for the complex system must be performed by authorized service representatives to ensure safety and proper functioning.
Implementation Complexity
The system is designed for gradual adoption into existing diagnostic workflows, supported by training from breast ultrasound experts. It requires operation by trained and qualified healthcare providers due to its complex nature.
Evidence Base
Supported by multicenter clinical studies, including the PIONEER study (2105 women across 16 U.S. sites) and the Reader-02 Pivotal study, which demonstrated improved specificity over ultrasound alone for BI-RADS 3-5 masses. Preliminary data from the CONFIDENCE Registry suggests a potential 75% reduction in unnecessary biopsies. A real-world use study of the second-generation system confirmed clinical acceptability, superior image quality, and increased specificity without loss of sensitivity, with SenoGramu00ae achieving 100% sensitivity and 64.3% specificity in a limited imaging study.
Physician Tip

Leverage the Imagio Breast Imaging System for its unique optoacoustic capabilities to gain functional information (vascularity and oxygenation) in real-time, especially for BI-RADS 3-5 lesions, to improve diagnostic accuracy and potentially reduce unnecessary biopsies. Utilize the integrated SenoGramu00ae AI for objective decision support in BI-RADS classification and Likelihood of Malignancy assessment. The non-invasive nature and real-time results can significantly enhance patient care pathways and reduce anxiety.

The Imagio system is designed for seamless integration into existing breast imaging diagnostic workflows. While it functions as a standalone cart-based system, its design emphasizes mobility and user-friendly interaction within clinical environments. Training and certification are crucial for optimal integration and utilization of its advanced optoacoustic and AI features.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentOn-premise (medical imaging system)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Imagio® Breast Imaging System received U.S. FDA approval on January 11, 2021, under Premarket Approval (PMA) P200003. It is indicated for use by trained healthcare providers for the evaluation of palpable and non-palpable breast abnormalities in adult patients referred for diagnostic imaging work-up, particularly for BI-RADS 3-5 masses.
Integrations
EHR Not specified
Specialties General Surgery, Oncology, Radiology

What the Web Says

The Imagio Breast Imaging System by Seno Medical is a diagnostic tool that combines opto-acoustic (light and sound) technology with traditional ultrasound and artificial intelligence (AI) to help differentiate between benign and malignant breast masses. It aims to improve diagnostic confidence, reduce unnecessary biopsies, and streamline the breast cancer diagnostic pathway. The system has received FDA approval and has been recognized with an Innovative Technology contract.

Overall: Positive

Strengths

  • Increases diagnostic confidence for physicians by providing functional and anatomical information.
  • Reduces the number of unnecessary breast biopsies for benign findings, leading to less patient anxiety, discomfort, and healthcare costs.
  • Non-invasive, does not use ionizing radiation (X-rays), contrast agents, or require breast compression.
  • Provides real-time information, potentially allowing for same-day results and streamlined care pathways.
  • Integrates into existing diagnostic workflows and includes an AI-driven decision support tool (SenoGram) to assist with BI-RADS classifications.
  • Superior image quality and increased specificity without loss of sensitivity compared to the first-generation device.

Limitations

  • Not indicated for ultrasound BI-RADS 1 and 2 findings.
  • Should not be used in pregnant individuals or those with open sores, phototoxicity from certain drugs, phototherapy, or photosensitive diseases.
  • Limited real-world use studies, with the second-generation system's first study involving 38 patients.
  • No specific reviews from healthcare IT, tech reviewers (outside of medical imaging news), G2, or Capterra were found directly for the Imagio system.

Based on reviews from: Imaging Technology News, Seno Medical, FDA, PR Newswire, PubMed, Reddit, WP Global Partners

Last updated: 2026-07-19

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Press & Coverage

OEM News
Imagio Breast Imaging Tech Proves its Clinical Viability in Study
A new study indicates that the second generation of Seno Medical Instruments Inc.'s Imagio Breast Imaging System, which combines light, sound, and AI, is equal or superior to its predecessor. The study, the first real-world use analysis of the second-generation system, assessed breast abnormalities in 38 patients and confirmed the clinical acceptability of modifications for the market-ready product.
2024-12
GlobeNewswire
Seno Medicalu00ae Receives Innovative Technology Contract from Vizient For its Imagiou00ae Breast Imaging System
Seno Medical's Imagiou00ae Breast Imaging System has been awarded an Innovative Technology contract from Vizient, Inc., a healthcare performance improvement company. This contract signifies that hospital experts recognize the Imagiou00ae System's unique qualities and its potential to improve the healthcare industry.
2024-11
Medimaging.net
Innovative Technology Integrates Laser Optics with Ultrasound to Enhance Breast Cancer Diagnosis
Seno Medical's Imagio Breast Imaging System, which received FDA Pre-Market Approval in 2021, integrates laser optics with ultrasound to provide real-time opto-acoustic/ultrasound (OA/US) exams for breast cancer diagnosis. This technology aims to reduce unnecessary breast biopsies by offering functional information about oxygenation and deoxygenation around suspicious masses.
2024-01
Seno Medical Press Releases
American Medical Association Issues New CPT Code for Use of Seno Medical's Opto-acoustic Technology in Breast Cancer Diagnosis
The American Medical Association (AMA) has issued a new Category III CPT code (0857T) for the Imagiou00ae Breast Imaging System, effective January 1, 2024. This code provides a pathway for healthcare providers to seek coverage and reimbursement for using Seno Medical's opto-acoustic technology in breast cancer diagnosis.
2024-01
Imaging Technology News
Carolina Breast Imaging Specialists, PLLC Is First in Nation to Adopt Groundbreaking Imagio Breast Imaging System for Breast Cancer Diagnosis
Carolina Breast Imaging Specialists, PLLC in Greenville, North Carolina, became the first radiology center in the U.S. to adopt the Imagio Breast Imaging System. This system uses non-invasive opto-acoustic ultrasound (OA/US) technology to provide real-time information on suspicious breast lesions, aiming to reduce unnecessary biopsies.
2023-08
AJR Online
Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses
This study investigates the positive predictive value of optoacoustic ultrasound features in benign and malignant breast masses. The Imagio Breast Imaging System integrates laser optics with gray-scale ultrasound, producing high-resolution images with co-registered real-time optoacoustic color maps that show hemoglobin amount and relative deoxygenation within and around breast masses.
2022-12
AuntMinnie.com
Seno Medical commercially launches Imagio breast imaging system - AuntMinnie
Optoacoustic imaging firm Seno Medical Instruments officially launched its commercially available Imagio breast imaging system at RSNA 2022. The system combines noninvasive ultrasound and optoacoustic technology to provide real-time information about breast lesions, including a unique blood map around suspicious masses.
2022-11
WP Global Partners
Seno Receives FDA PMA Approval for Imagio Breast Imaging System
Seno Medical's Imagiou00ae Breast Imaging System received supplemental premarket approval (PMA) from the FDA's Center for Devices and Radiological Health (CDRH). This approval allows the system, which uses non-invasive opto-acoustic/ultrasound (OA/US) technology, to help differentiate between benign and malignant breast lesions in real time.
2022-07

Videos

Product demos, reviews, and walkthroughs for Imagio Breast Imaging System.

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Frequently Asked Questions

The SenoGramu00ae AI tool assists radiologists by providing image reference keys and objectively translating optoacoustic/ultrasound (OA/US) feature scores into a Likelihood Of Malignancy (LOM), improving diagnostic accuracy and confidence in BI-RADS classifications. It is specifically indicated for evaluating ultrasound BI-RADS 3-5 masses to improve classification compared to ultrasound alone.
The Imagio Breast Imaging System, including its AI-based software function, has received FDA approval. However, the responsible integration of AI in healthcare requires adherence to ethical principles such as transparency, accountability, and patient safety, with ongoing discussions around regulatory frameworks for AI in breast imaging.
The Imagio System combines optoacoustic and ultrasound imaging to provide both anatomical and functional information, such as blood oxygen levels and vascularity, which is not typically available with conventional ultrasound or mammography. This unique functional data, enhanced by AI, aims to improve specificity and reduce unnecessary biopsies, offering a different diagnostic pathway compared to modalities primarily focused on morphological assessment.
The Imagio System, with its AI-driven SenoGramu00ae, aims to improve diagnostic specificity, which can lead to a reduction in false positives and, consequently, fewer unnecessary breast biopsies. This reduction in biopsies can significantly lower healthcare costs and alleviate patient anxiety associated with invasive procedures.
The Imagio System is contraindicated for pregnant patients, those with open sores on the ipsilateral breast, or individuals experiencing phototoxicity or with a history of photosensitive diseases. While the AI assists in BI-RADS classification for specific masses, it is not indicated for BI-RADS 1 and 2 findings and should not replace mammographic screening or definitive pathologic diagnosis.
The SenoGramu00ae AI tool provides clinical decision support to radiologists, aiding in objective BI-RADS classification and likelihood of malignancy assessment, rather than replacing their expertise. It is designed to assist users and enhance confidence, with the understanding that a trained and qualified healthcare provider must operate the device and interpret the results.
While specific protocols for Imagio are not detailed in the provided search results, general concerns for AI in medical imaging include data privacy, security, and bias. Implementing AI in breast imaging requires robust legal and ethical frameworks to ensure patient safety and data protection.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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