Retrospective Study of Seno Medical’s Imagio® Breast Imaging System Published in American Journal of Roentgenology Shows System May Help Reduce Biopsies of Benign Breast Masses Compared to Ultrasound Alone

Study found OA/US fused imaging significantly improved specificity at fixed sensitivity compared to conventional ultrasound 

[SAN ANTONIO, TX – January 5, 2023] A retrospective study of Seno Medical‘s Imagio^® Breast Imaging System published in the American Journal of Roentgenology found that the company’s opto-acoustic/ultrasound (OA/US) technology significantly improves specificity at fixed sensitivity compared to conventional ultrasound. The study, Optoacoustic Imaging with Decision Support for Differentiation of Benign and Malignant Breast Masses: A 15-Reader Retrospective Study, shows that optoacoustic imaging with decision support may help reduce biopsies of benign breast masses compared with grayscale ultrasound interpretation alone, while maintaining 98 percent sensitivity for cancer.

Led by Stephen Seiler, MD, University Texas Southwestern Medical Center, Dallas, TX, the study’s objective was to compare ultrasound images alone and fused OA/US images for specificity at a fixed sensitivity evaluated with machine learning-based decision support tool (DST) assistance. The reader study included 480 patients with 480 breast masses that had been classified by conventional grayscale ultrasound. Fifteen readers independently reviewed the acquired images after training in OA/US imaging interpretation. 

Specificity at fixed sensitivity of 98 percent was significantly higher for OA/US images with DST assistance than for ultrasound alone (47.2 percent vs 38.2 percent). Better performance for fused OA/US images with DST assistance than for ultrasound was observed for 14 out of 15 readers. All readers (15/15) partial area under the curve was statistically higher for OA/US with DST than for ultrasound alone.

The authors of the study concluded that, “Fixed ultrasound and optoacoustic images with DST assistance provided significantly improved specificity at fixed sensitivity compared with conventional ultrasound alone.”

Recently honored with a Gold Edison award, a Gold Medical Design Excellence Award and as a semi-finalist in the 2022 Minnies for its medical innovation, Seno’s groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize masses that may — or may not — require more invasive diagnostic evaluation. 

Breast biopsy procedures caused by false-positive diagnostic assessments cost the US healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could significantly reduce those costs with its patient-centric OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional, morphological, 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 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 help physicians interpret the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more precisely assign the likelihood of malignancy. 

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 developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021 with a Supplemental PMA Approval for its latest device in June 2022, 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.