FDA Approves New Imaging Features on Hologic 3Dimensions Mammography System

crnksrcbu

first_img News | PACS | August 09, 2019 Lake Medical Imaging Selects Infinitt for Multi-site RIS/PACS Infinitt North America will be implementing Infinitt RIS (radiology information system)/PACS (picture archiving and… read more ReferencesResults from Friedewald, SM, et al. “Breast cancer screening using tomosynthesis in combination with digital mammography.” JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia® Dimensions® on screening outcomes. Individual results may vary. The study found an average 41% increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1,000 screening exams were found in women receiving combined 2D FFDM and 3D™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only.  FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005.  Compared to C-view  Compared to 2D alone  Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00019 Rev 003 (2017).  FDA 510(k) K163623  Understanding Quantra™ (Version 2.2) User Manual FacebookTwitterLinkedInPrint分享 Technology | Mammography | March 28, 2018 FDA Approves New Imaging Features on Hologic 3Dimensions Mammography System High-resolution 3-D imaging and Intelligent 2-D imaging technology now approved on Hologic’s latest digital breast tomosynthesis system read more IBM collected a dataset of 52,936 images from 13,234 women who underwent at least one mammogram between 2013 and 2017, and who had health records for at least one year prior to the mammogram. The algorithm was trained on 9,611 mammograms. Image courtesy of Radiology. News | Mammography | August 14, 2019 Imago Systems Announces Collaboration With Mayo Clinic for Breast Imaging Image visualization company Imago Systems announced it has signed a know-how license with Mayo Clinic. The multi-year… read more Technology | Breast Biopsy Systems | July 24, 2019 Fujifilm Releases Tomosynthesis Biopsy Option for Aspire Cristalle Mammography System Fujifilm Medical Systems U.S.A. Inc. recently expanded its breast imaging solutions with the launch of its… read more March 28, 2018 — Hologic Inc. announced that Clarity HD high-resolution 3-D imaging and Intelligent 2-D imaging technology have received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) and are now available on the 3Dimensions breast tomosynthesis system. With these innovations, the system now provides higher resolution 3-D breast images for radiologists, enhanced workflow for technologists, and a more comfortable mammography experience with low-dose options for patients.Hologic originally released the Genius 3-D Mammography exam, first approved by the FDA in 2011 on the company’s 3-D Mammography system. Today, Hologic has installed more than 5,000 3-D Mammography systems throughout the United States and is continuing to help ensure insurance coverage is available for all women. More than 90 percent of women ages 40 to 75 currently have coverage for the Genius exam, and more than 16 million women in the U.S. get a Genius exam each year. The Genius exam detects 20-65 percent more invasive breast cancers and is the only mammogram approved by the FDA as superior for women with dense breasts compared to 2-D alone.1,2The new Clarity HD high-resolution 3-D imaging technology provides what Hologic calls the industry’s fastest, highest resolution 3-D images to accelerate screening and analysis, and is designed to clearly reveal subtle lesions and fine calcifications to help pinpoint cancers early. Clarity HD technology’s advanced detector and innovative 3-D imaging algorithm work together to deliver high-quality 3-D images, regardless of breast size or density.Intelligent 2-D imaging technology works with Clarity HD technology to deliver superior overall image quality, and clarity, contrast and detail at a lower dose.3,4Another new feature, the SmartCurve breast stabilization system, is clinically proven to deliver a more comfortable mammogram without compromising image quality, workflow or dose.5 The SmartCurve system has been proven to improve comfort in 93 percent of women who reported moderate to severe discomfort with standard compression.5 It features a curved compression surface that mirrors the shape of a woman’s breast to reduce pinching and allow uniform compression over the entire breast.In addition, Quantra 2.2 Breast Density Assessment Software, also available on the 3Dimensions system, enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings. Breast density is only identifiable on a mammogram or other screening modality, and has historically been determined by the radiologist who reads the image. Through a proprietary algorithm powered by machine learning, Quantra software analyzes mammography images for distribution and texture of breast tissue, delivering clinicians accurate breast density assessment. Quantra software categorizes breasts into four density categories, in alignment with the American College of Radiology Breast Imaging-Reporting and Data System (ACR BI-RADS) Atlas 5th Edition.6,7The Genius 3-D Mammography exam (also known as the Genius exam) is only available on a Hologic 3-D Mammography system. The Genius exam consists of a 2-D and 3-D image set, where the 2-D image can be either an acquired 2-D image or a 2-D image generated from the 3-D image set.For more information: www.hologic.com Image courtesy of Imago Systems 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 center_img Technology | Mammography Reporting Software | July 25, 2019 Hologic Partners With MagView to Develop Unifi EQUIP Solution Hologic announced a partnership with mammography information solutions provider MagView to develop Unifi EQUIP, an… read more 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 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 | Mammography Reporting Software | July 26, 2019 Ikonopedia Releases Automated Combined Reporting Package at AHRA Ikonopedia showcased its recently released Automated Combined Reporting package and its entire suite of structured… read more News | Breast Imaging | August 02, 2019 Volpara to Distribute Screenpoint Medical’s Transpara AI Solution Volpara Solutions and ScreenPoint Medical BV signed an agreement under which Volpara will sell ScreenPoint’s Transpara… read more News | Artificial Intelligence | August 13, 2019 Artificial Intelligence Could Yield More Accurate Breast Cancer Diagnoses University of California Los Angeles (UCLA) researchers have developed an artificial intelligence (AI) system that… 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). Related Contentlast_img

Leave a Reply

Your email address will not be published. Required fields are marked *