Seno Medical Launches CONFIDENCE Registry Study for the Imagio® Breast Imaging System | Nation / World
San Antonio, TX, October 21, 2021 (GLOBE NEWSWIRE) – Texas-based Seno Medical Instruments, Inc. (Seno) has launched its CONFIDENCE registry to assess the effectiveness of opto-acoustic / ultrasound imaging (OA / US ) to diagnose breast abnormalities, including cancer, using its revolutionary Imagio® breast imaging system. About twelve sites will participate in the international registry, with a target of more than 600 total patients participating throughout the study period, ending in 2024.
Several international sites in the Netherlands are currently recruiting for the study. The objective of the study is to obtain real post-market data on the use of the Imagio® system and to provide evidence of the general use and performance of the system in a real environment.
“We believe that, just like other hybrid imaging modalities such as PET / CT, the sum of optoacoustics and ultrasound provides greater sensitivity and specificity than either. individual imaging modalities, ”said Shaan Schaeffer, vice president of clinical operations at Seno.
The CONFIDENCE registry parameters to analyze include:
- Specificity, negative likelihood ratio, sensitivity and positive likelihood ratio for the Imagio® system compared to other standard imaging modalities,
- Use of the Imagio® system in comparison and in combination with other imaging modalities to influence the biopsy decision,
- Quality of life assessment – Morbidity index test,
- In malignant masses, evaluation of the roles of OA / US as a prognostic biomarker,
- Characteristics of the lesions / masses of the lymph nodes for which the device is used.
Breast biopsy procedures caused by false positive diagnostic evaluations in the United States cost the healthcare system more than $ 2 billion per year.i Seno’s Imagio® technology could mitigate this with its non-invasive OA / US technology for helping physicians better differentiate malignant breast lesions in real time, helping providers characterize and differentiate masses that may or may not require more invasive diagnostic evaluation.
Seno CEO Tom Umbel commented: “This registry study will help us justify the effectiveness of the Imagio® system in a real world setting and the ability of OA / US to benefit physicians and patients. of the whole world.
The company’s OA / US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. Optoacoustic images provide a unique blood map in and around breast masses, while ultrasound provides a traditional anatomical image. By the appearance or absence of two characteristic indicators of cancer – angiogenesis and deoxygenation – Seno Medical has shown that the Imagio® OA / US breast imaging system will be a more effective tool to help radiologists confirm or exclude malignancy over traditional diagnostic imaging modalities – without exposing patients to ionizing radiation (x-rays) or potentially harmful contrast agents. In addition to the new imagery provided by the Imagio® system, Seno includes an artificial intelligence (AI) decision support tool (the SenoGram®) to help physicians interpret the new images which, along with training and certification, help radiologists make the transition from ultrasound alone to OA / US imaging.
The system is indicated for use by trained and qualified healthcare providers to assess palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast exam following clinical presentation or breast cancer. ” other imaging tests such as a screening mammogram.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company engaged in the development and commercialization of a novel cancer diagnostic modality: optoacoustic imaging. Approved by the US FDA in January 2021, Seno Medical’s Imagio® Breast Imaging System merges optoacoustic technology with ultrasound (OA / US) to generate functional and anatomical images of the breast in real time. To learn more about Seno Medical’s OA / US imaging technology and applications, visit www.SenoMedical.com.
i Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of use patterns and associated costs of breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018; 10: 157-167.
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