Imagio Breast Imaging System
Seno Medical Instruments, Inc.The Imagio Breast Imaging System is a diagnostic tool that combines optoacoustic imaging and ultrasound to provide detailed structural and functional information about breast abnormalities. It uses AI-based software to help healthcare providers better classify breast masses, thereby improving diagnosis. The device is designed to assist, not replace, mammographic screening or biopsy.
Intended Use
The Imagio Breast Imaging System is indicated for evaluation of palpable and non-palpable breast abnormalities in adult patients referred for diagnostic breast imaging work-up, combining ultrasound and optoacoustic imaging with an AI-based tool to assist in mass classification.
Technology
The device integrates pulsed laser optoacoustic imaging with conventional ultrasound imaging, using dual near-infrared wavelengths to estimate hemoglobin oxygen saturation in breast tissue. It acquires co-registered structural ultrasound and functional optoacoustic images in real-time with a handheld probe and utilizes a machine learning software tool (SenoGram) to assist users in assessing BI-RADS classification and malignancy probability from reader-input feature scores.
Performance
Performance testing included extensive nonclinical laboratory validation for image quality, spatial resolution, co-registration accuracy, and oxygen saturation measurement. A pivotal multi-reader, multi-case clinical study (Reader-02) using data from over 1900 patients demonstrated that adding optoacoustic imaging to ultrasound significantly improved specificity for breast mass classification at a fixed 98% sensitivity. The AI-based SenoGram software showed high sensitivity (97.0%) and improved specificity (50.9%) in detecting malignancy. Safety data indicate low rates of mild adverse events and no serious adverse device effects.
Device Timeline
- 1
Submission
1/31/2020
11 months - 2
FDA Approval
1/11/2021
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