Device Name: Imagio Breast Imaging System
Author(s): Michael Josephson, MD, Kate Lak, MD
Seno Medical received FDA approval for its Imagio Breast Imaging System on January 11, 2023.
The Imagio Breast Imaging system is a diagnostic functional and morphological imaging system that combines conventional diagnostic ultrasound imaging with opto-acoustic (OA) imaging to aid in diagnostic evaluation of breast lesions. OA imaging combines ultrasound with laser optics to provide a combined view of both tissue anatomy and blood flow. This technology takes advantage of two characteristics typical of cancerous lesions: they typically have a high density of new blood vessels as a result of angiogenesis and they have a lower oxygen saturation compared to surrounding tissue. First, ultrasound mode is used to assess any focal areas of clinical or imaging concern. Then, for BI-RADS 3-5 lesions, OA images allow for improved classification compared to ultrasound alone. An artificial intelligence-based software function (SenoGram) is included to assist users with BI-RADS classifications and calculate a likelihood of malignancy score (LOM).
The Imagio Breast Imaging System has been evaluated in several non-clinical laboratory and phantom tissue studies to demonstrate safety and effectiveness as well as its ability to characterize and quantify images, detect vessels, and measure oximetry. The primary clinical study, the Reader-02 Pivotal study, was a single-arm sequentially read multi reader/case (MRMC) study comparing internal ultrasound (IUS) vs Imagio (IUS+OA). This study demonstrated that the Imagio Breast Imaging System has better specificity than IUS at characterizing BI-RADS 3-5 masses of interest and supports its use as a diagnostic breast imaging device.
The ultrasound component of the device is based on the previously cleared Imagio Ultrasound imaging system (K182628). The probe, L14-5/38 (Analogic Corporation), has been previously evaluated and cleared under K089035.
The ultrasound component of the Imagio Breast Imaging System may be used for any palpable or non-palpable lesions for determination of BI-RADS classification, but Opto-Acoustic (OA) mode is intended for further classification of BI-RADS 3-5 lesions only.
The device is contraindicated in pregnant patients, those with open sores, those with a history of photosensitivity or those currently experiencing phototoxicity.