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first_img March 2, 2012 — U-Systems announced the somo•v automated breast ultrasound (ABUS) system is scheduled for review by the Radiological Devices Panel of the U.S. Food and Drug Administration (FDA) on April 11, 2012. The FDA Advisory Panel review is the next step in the firm’s premarket approval (PMA) application seeking a breast cancer screening indication for the system. The somo•v ABUS system is currently FDA-cleared for diagnostic use as an adjunct to mammography.“We are very excited the somo•v ABUS system has been scheduled for review at the upcoming Radiological Devices Advisory Panel meeting,” said Ron Ho, president and CEO of U-Systems. “This is a significant milestone, not only for the company, but also for women with dense breast tissue. The limitation of mammography in women with dense breasts is well documented. This panel review, part of the FDA process for assessing new technology, brings us one step closer to an approved adjunctive screening tool for women with dense breasts. This is vitally important, because an estimated 40-45 percent of women in the United Stated have dense breast tissue.”Dense breast tissue not only increases the risk of breast cancer up to four to six times but also makes cancer more difficult to detect via mammography according to multiple large studies. A study published in the New England Journal of Medicine showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as the density masks appearance of tumors. The greater the breast density, the lower the mammogram accuracy.Over the past several years, U-Systems has worked with some of the nation’s leading breast imaging experts to conduct a large, multi-center prospective clinical study to evaluate the ability of somo•v automated breast ultrasound screening to improve cancer detection rates for women with dense breast tissue. The SOMO•INSIGHT clinical study, the largest trial ever undertaken by an ultrasound company, is designed to evaluate whether digital mammography in combination with the automated breast ultrasound system is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue. More than 16,000 women have enrolled in the study at multiple breast imaging centers nationwide.For more information: www.u-systems.com FacebookTwitterLinkedInPrint分享 Image courtesy of Imago Systems Technology | Artificial Intelligence | July 18, 2019 Paragon Biosciences Launches Qlarity Imaging to Advance FDA-cleared AI Breast Cancer Diagnosis System Paragon Biosciences LLC announced the launch of its seventh portfolio company, Qlarity Imaging LLC, which was founded… read more Feature | Artificial Intelligence | July 19, 2019 | Michal Chorev AI Models Predict Breast Cancer With Radiologist-level Accuracy Breast cancer is the global leading cause of cancer-related deaths in women, and the most commonly diagnosed cancer… read more News | Ultrasound Women’s Health | July 11, 2019 FDA Clears Koios DS Breast 2.0 AI-based Software Koios Medical announced its second 510(k) clearance from the U.S. Food and Drug Administration (FDA). 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The multi-year… read more News | March 02, 2012 FDA Panel Meeting Scheduled for U-Systems’ Automated Breast Ultrasound (ABUS) System The somo•v Automated Breast Ultrasound is the First Ultrasound Device to Target Breast Cancer Screening Indication Related Content Qlarity Imaging’s software is used to assist radiologists in the assessment and characterization of breast lesions. Imaging features are synthesized by an artificial intelligence algorithm into a single value, the QI score, which is analyzed relative to a database of reference abnormalities with known ground truth. Image courtesy of Business Wire. News | Artificial Intelligence | July 03, 2019 Therapixel Appoints Matthieu Leclerc-Chalvet as CEO Artificial intelligence (AI) breast cancer screening specialist Therapixel announced the appointment of Matthieu… read morelast_img read more