The Imagio Breast Imaging System helps physicians differentiate between benign and malignant breast lesions using a novel combination of ultrasound and optoacoustic technology. Image courtesy of Seno Medical.

Recently recognized with a Gold Edison award, a Gold Medical Design Excellence Award, and as a semifinalist in the Minnies 2022 competition for its medical innovation, Seno's groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using noninvasive optoacoustic/ultrasound (OA/US) technology to provide information about breast lesions in real-time, helping providers to characterize masses that may -- or may not -- require more invasive diagnostic evaluation.

In support of the launch at RSNA, Seno Medical will bring its category-defining Imagio System to the doorsteps of clinicians and healthcare providers throughout the U.S. with its mobile education and demonstration tour, Imagio OA/US Road Show - Scans Across America. The hands-on tour, which began this summer and is scheduling stops across the country throughout the coming year, enables onsite demonstrations of the Imagio System.

The market-ready Imagio System received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) in June of this year; it incorporates the latest in ultrasound imaging technology required for premier breast imaging centers, as well as advanced ultrasound technology integrated into the optoacoustic probe, a new ultrasound probe, and elimination of redundant electronics, making this version of Imagio ergonomic and truly disruptive for the marketplace with its novel technological advances.

Tom Umbel, president and CEO of Seno Medical, commented, "The time has come for the market to start adopting and using this groundbreaking new hybrid modality for breast imaging, and we are proud to be showcasing it at RSNA."

Breast biopsy procedures, caused by false-positive diagnostic assessments, cost the US healthcare system more than $2 billion per year.¹ Seno's Imagio technology could significantly reduce those costs with its noninvasive OA/US innovation.

Seno's OA/US system combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The optoacoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer -- angiogenesis and hypoxia -- Seno Medical has shown that the Imagio OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents.

In addition to the novel imaging provided by the Imagio System, Seno includes an artificial intelligence (AI) decision-support tool (SenoGram) to aid physicians in interpreting the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging.

Seno Medical Instruments is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: optoacoustic imaging. Originally approved by the US FDA in January 2021, Seno Medical's Imagio Breast Imaging System fuses optoacoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical's OA/US imaging technology and applications, visit SenoMedical.com.

Indication statement: The Imagio 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.

The comments and observations expressed are those of the author and do not necessarily reflect the opinions of AuntMinnie.com.

1. Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-1