The Imagio Breast 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 and differentiate masses that may — or may not — require more invasive diagnostic evaluation.
July 26, 2022 —Seno Medical’s Imagio Breast Imaging System, a revolutionary new modality in breast imaging, has received supplemental premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA). Seno’s market-ready, groundbreaking diagnosticbreast cancer imaging systemhelps physicians differentiate between benign and malignantbreast lesionsusing non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize and differentiate masses that may — or may not — require more invasive diagnostic evaluation.
TheImagio Breast Imaging System整合了一流的乳房成像中心所需的最先进的超声成像技术，以及先进的超声技术集成到光声探头，一种新的超声探头，并消除多余的电子设备，使这个版本的Imagio更符合人体工2022世界杯篮球预选赛赛程程学，并真正以最新的技术进步颠覆市场。
Tom Umbel, President and CEO of Seno Medical, commented, “This team is passionately committed to providing a revolutionary leap forward in patient care, and our commercial version of our Imagio System delivers just that. With our novel OA/US platform, combined with the latest technologies available today in breast imaging, we are delivering a new hybrid modality that will help providers deliver the best care possible to their patients.”
The company is launching a mobile education and demonstration tour,Imagio OA/US Road Show- Scans Across America, to enable on-site, hands-on demonstration with the Imagio System throughout the United States. The Imagio OA/US Road Show - Scans Across America tour will begin in late July with continued stops across the countbreastry throughout 2022.
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 non-invasive OA/US innovation.
Seno公司的OA/US系统结合了激光光学和灰度超声，提供融合的功能性和解剖学乳房成像。2022世界杯篮球预选赛赛程光声图像提供了乳房肿块及其周围独特的血液图谱，而超声提供了传统的解剖图像。通过肿瘤的两个标志性指标——血管生成和缺氧——的出现或消失，Seno Medical已经表明，Imagio OA/US乳腺成像系统与传统的诊断成像方式相比，将是帮助放射科医生确认或排除恶性肿瘤的更有效的工具。2022世界杯篮球预选赛赛程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.
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 screeningmammography.
For more information:www.SenoMedical.com
Reference:[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.
July 28, 2022
