Seno Medical’s Imagio® Breast Imaging System makes use of non-invasive opto-acoustic ultrasound (OA/US) expertise to offer data on suspicious breast lesions in actual time, serving to suppliers characterize and differentiate lots which will – or could not – require extra invasive diagnostic analysis.
San Antonio, TX, Jan. 19, 2021 (GLOBE NEWSWIRE) — The Middle for Units and Radiological Well being (CDRH) of the US Meals & Drug Administration (FDA) has granted Texas-based Seno Medical Devices, Inc. (Seno) premarket approval (PMA) for its groundbreaking diagnostic breast most cancers imaging expertise that helps physicians higher differentiate between benign and malignant breast lesions. The corporate’s Imagio® Breast Imaging System makes use of non-invasive opto-acoustic ultrasound (OA/US) expertise to offer data on suspicious breast lesions in actual time, serving to suppliers characterize and differentiate lots which will – or could not – require extra invasive diagnostic analysis.
Breast biopsy procedures brought on by false-positive diagnostic assessments in the USA value the healthcare system greater than $2 billion per 12 months.i Seno’s Imagio® expertise may mitigate that by giving suppliers extra real-time data concerning suspicious breast lots and elevated confidence to make a greater resolution concerning the necessity for diagnostic breast biopsies.
The corporate’s OA/US expertise combines laser optics and grayscale ultrasound to offer fused practical and anatomical breast imaging. The opto-acoustic pictures present a singular blood map in and round breast lots, whereas the ultrasound gives a conventional anatomical picture. Via the looks or absence of two hallmark indicators of most cancers – angiogenesis and deoxygenation – Seno Medical has proven that the Imagio® OA/US Breast Imaging system can be a simpler device to assist radiologists affirm or rule out malignancy in comparison with conventional diagnostic imaging modalities – with out exposing sufferers to doubtlessly dangerous ionizing radiation (x-rays) or distinction brokers. Along with the novel imaging supplied by the Imagio system, Seno contains an AI doctor resolution help device (the SenoGram®) to assist in deciphering the brand new pictures that, together with coaching and certification, assist radiologists make the transition from ultrasound alone to OA/US Imaging.
The system is indicated to be used by skilled and certified healthcare suppliers to judge palpable and non-palpable breast abnormalities in grownup sufferers who’re referred for diagnostic imaging breast work-up following scientific presentation or different imaging examinations reminiscent of screening mammography.
Seno’s Chief Govt Officer Tom Umbel commented, “We’re thrilled to have reached this milestone and are wanting ahead to shifting our expertise platform ahead within the U.S. with this FDA approval. Our inside crew and our trustworthy investigators and scientific trial websites have labored diligently to carry Imagio® to market and enhance take care of sufferers and suppliers with the exact diagnostic capabilities and enhanced decision-making help that our novel OA/US imaging gives.”
Seno’s Chief Medical Officer, A. Thomas Stavros, MD, FACR, FSBI, believes that Imagio® is establishing a greater normal for a way diagnostic modalities must be judged. “Optimizing the analysis of breast lots requires a mixture of very excessive sensitivity (≥98%) whereas concurrently maximizing specificity and minimizing false positives and biopsies of benign lots. Different modalities have reported enhancements in specificity, however these have typically come on the expense of the specified excessive ≥98% sensitivity. The info from the PMA examine exhibits that OA/US efficiently achieved improved specificity at a set sensitivity of 98%, the a part of the ROC curve the place scientific selections about whether or not or to not biopsy a mass are literally made.”
Seno Medical Devices, Inc. is a San Antonio, Texas-based medical imaging firm dedicated to the event and commercialization of a brand new modality in most cancers analysis: opto-acoustic imaging. Seno Medical’s Imagio® Breast Imaging System fuses opto-acoustic expertise with ultrasound (OA/US) to generate real-time practical and anatomical pictures of the breast. To be taught extra about Seno Medical’s OA/US imaging expertise and functions, go to www.SenoMedical.com.
i Vlahiotis A, Griffin B, Stavros AT, Margolis J. Evaluation of Utilization Patterns and Related Prices of the Breast Imaging and Diagnostic Procedures After Screening Mammography. ClinicoEconomics and Outcomes Analysis 2018:10 157-167.
Tom Umbel Seno Medical (210) 714-1912 tumbel@senomedical.com
