Imagio Breast Imaging Tech Proves its Clinical Viability in Study

The second generation of Seno Medical Instruments Inc.’s Imagio Breast Imaging System—which combines light, sound, and artificial intelligence (AI)—is equal to or superior to the company’s first-generation device, according to a new study.

The analysis is the first real-world use study of the second-generation Imagio System. The trial assessed palpable and non-palpable breast abnormalities in 38 patients who required diagnostic breast ultrasound workups and confirmed the clinical acceptability of modifications made to the Imagio System for its market-ready product as compared to its first-generation system.

“This is the first real world use study of the market-ready Imagio Breast Imaging System and confirms that in day-to-day clinical practice, OA imaging is providing breast imagers with the diagnostic confidence they’ve been seeking,” Seno Medical CEO Tom Umbel stated. “Our technology allows for a simplified care pathway that improves patient care and helps reduce unnecessary exams and costs of diagnosing breast cancer.”

The study author concluded Imagio’s ultrasound combined with Seno’s opto-acoustics imaging performed equal to or better than the first-generation device, with superior image quality and increased specificity without the loss of sensitivity. In this limited imaging study, using the SenoGram AI decision support tool provided an observed 100% sensitivity and 64.3% specificity. The combination of opto-acoustic imaging and AI provided by the Imagio System helped distinguish masses, providing functional biologic data and imaging appearance in an efficient, effective, and cost-conscious manner. According to the authors, “The functional imaging of OA/US together with the DST (SenoGram) does offer an objective and tightly calibrated method of predicting FNRs below 2% and even at and below 0.5%.”

Opto-acoustic imaging is a category-defining technology that combines functional (opto-acoustics or photoacoustics), anatomic (ultrasound) and morphologic information using light (laser optics or opto-acoustics)  and sound waves plus proprietary artificial intelligence (SenoGram) decision support to produce high-resolution, high- contrast images for clinicians. The result is a diagnostic imaging modality that delivers functional information regarding suspicious breast masses, increasing confidence regarding the need for invasive breast cancer diagnostic biopsies.

Imagio is non-invasive, has no ionizing radiation, does not use contrast agents, and does not require the compression required in mammography. Imagio provides clinicians with real-time information and the ability to provide same-day results. Incorporating Imagio into a center can improve workflow efficiency and help lower stress and anxiety in patients, according to Seno Medical.

The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.

Seno Medical Instruments Inc. is a San Antonio, Texas-based medical imaging company committed to improving the efficiency and reducing the complexity of breast cancer diagnostics through its new modality: opto-acoustic imaging. Approved by the U.S. Food and Drug Administration in January 2021, with supplemental approval in June 2022, Seno’s Imagio Breast Imaging System is a new modality combining light, sound, and A.I. to provide information not previously available to the breast imager. The result is substantially improved confidence in diagnostic results that leads to real-time assessments, streamlined care pathways, and reductions in false-positive biopsies. The company was recognized by Frost & Sullivan with its 2023 Enabling Technology Leadership award for its approach to diagnostic imaging.