Seno Medical’s Imagio^® Breast Imaging System Named Finalist for Medical Device Excellence Awards

[SAN ANTONIO, TX – March 29, 2022] Seno Medical’s Imagio^® Breast Imaging System has been named a finalist in the 2022 Medical Device Excellence Awards, in the Radiological, Imaging, and Electromechanical Devices category.

The Medical Design Excellence Awards (MDEA) is the premier awards program for the medtech industry. Since its inception in 1998, the mission of the MDEAs has been to recognize significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Final winners will be announced in April.

“Innovation and passion are the foundational building stones of Seno Medical, and we are so honored to be a finalist in this prestigious program that celebrates these qualities in medtech,” Tom Umbel, Seno’s Chief Executive Officer, commented.

Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could reduce those costs with its non-invasive OA/US technology to help physicians better differentiate between benign and malignant breast lesions in real time, helping providers characterize and differentiate masses that may—or may not—require more invasive diagnostic evaluation.

The company’s OA/US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic 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 to traditional diagnostic imaging modalities – 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 (the SenoGram^®) to aid physicians in interpreting the new images that, along with training and certification, helps radiologists make the transition from ultrasound alone to OA/US imaging.

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 the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021, Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic 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 www.SenoMedical.com.

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[i] 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;10:157-167.