FDA's Breakthrough Device Program ... - OF DIGITAL INTEREST FDA breakthrough designations grow since 2019: Where do orthopedic devices stand? This is Anumana's second technology to receive FDA Breakthrough Device Designation. IRVING, Texas, May 3, 2019 /PRNewswire/ -- Caris Life Sciences®, a leading innovator in molecular science focused on precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company's MI Transcriptome™ companion diagnostic (CDx) test. GERMANTOWN, Md., March 15, 2018 /PRNewswire/ -- 3i Diagnostics announced today that its new technology, called Biospectrix [TM] , for detecting and identifying bacteria directly from whole . Press Releases | Medtronic FDA grants breakthrough designation for AWAK's Peritoneal Dialysis device NEW HOPE, Pa., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Orchestra BioMed . Genetic Cancer Test Granted FDA Breakthrough Device Designation The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. Siemens' sNfL Assay for MS Receives Breakthrough Device Designation FDA Grants Breakthrough Device Designation for ... - Endovascular Today MEMPHIS, Tenn.--(BUSINESS WIRE) . The Breakthrough Device program was created by the 21st Century Cures Act. January 17, 2020 at 6:39 pm. Beta Bionics Receives FDA Breakthrough Device Designation Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and . Between 1 January 2019 and 1 January 2020, the number of. 3iDx received Breakthrough Device Designation from FDA - 3i Diagnostics "Along with the FDA Breakthrough Device Designations we received last year, CE Marking will help accelerate the . Designation Allows Expedited Review of First "Artificial Meniscus". Caris plans to submit the assay for FDA premarket approval in late 2019. . FDA grants IDE for MedAlliance's sirolimus-eluting balloon He is using an in vitro model to test the electrical stimulation technique that BioPrax™ employs to treat infections. The Caesarea, Israel-based company gained the designation for its interatrial shunt for heart failure.