FDA Approves Seno Medical’s Breakthrough Breast Cancer Diagnostic Technology
Seno’s Imagio® Breast Imaging System helps physicians differentiate benign and malignant breast lesions using a new combination of ultrasound and optoacoustic technology.
Seno Medical’s Imagio® Breast Imaging System uses non-invasive optoacoustic ultrasound (OA / US) technology to provide real-time information about suspicious breast lesions, helping providers characterize and differentiate masses that may or may not require a more invasive diagnostic evaluation.
San Antonio, TX, January 19, 2021 (GLOBE NEWSWIRE) – The Center for Devices and Radiological Health (CDRH) of the United States Food & Drug Administration (FDA) has granted Texas Séno Medical Instruments, Inc. (Seno) pre-market approval (PMA) for its revolutionary breast cancer diagnostic imaging technology which helps doctors better differentiate benign and malignant breast lesions. The company’s imagio® The breast imaging system uses non-invasive opto-acoustic ultrasound (OA / US) technology to provide information about suspicious breast lesions in real time, helping providers characterize and differentiate masses that may or may not. require a more invasive diagnostic evaluation.
Breast biopsy procedures caused by false positive diagnostic evaluations in the United States cost the health care system more than $ 2 billion annually.I Imagio de Seno® Technology could mitigate this by providing providers with additional real-time information on suspicious breast masses and increased confidence to make a better decision about the need for diagnostic breast biopsies.
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 Imagio® The OA / US Breast Imaging System will be a more effective tool in helping radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities – without exposing patients to ionizing radiation (x-rays) or radiation. potentially harmful contrast agents. In addition to the new imagery provided by the Imagio system, Seno includes an AI physician decision support tool (the SenoGram®) to help interpret the new images that, 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 CEO Tom Umbel commented, “We are delighted to have reached this milestone and look forward to advancing our technology platform in the United States with this FDA approval. Our internal team and our loyal investigators and clinical trial sites have worked diligently to bring Imagio® to market and improve care for patients and providers with the precise diagnostic capabilities and enhanced decision support that our new OA / US imaging provides.
Seno Chief Medical Officer A. Thomas Stavros, MD, FACR, FSBI, believes that Imagio® sets a better standard for how diagnostic modalities are to be judged. “Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (≥ 98%) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses. Other modalities have reported improvements in specificity, but these often occurred at the expense of the desired high sensitivity ≥ 98%. Data from the PMA study show that OA / US was successful in improving specificity at a fixed sensitivity of 98%, the part of the ROC curve where clinical decisions about whether or not to biopsy a mass are actually made. . “
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. Imagio by Seno Medical® The breast imaging system merges opto-acoustic 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 and Outcomes Research 2018: 10 157-167.
CONTACT: Tom Umbel Seno Medical (210) 714-1912 [email protected]