fda breakthrough device designation 2019
October 24, 2023
The breakthrough designation was granted by the FDA after reviewing the results from the First-In-Human safety trial of AWAK PD device which was successfully completed at the Singapore General Hospital in October 2018. The FDA intends to request any other information needed to inform the Breakthrough Device designation decision within 30 days of receiving your request. AWAK Technologies Wearable Peritoneal Dialysis Device May 2, 2019 | Renalytix AI announced today that it has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX. Omar Ford | Aug 16, 2019. August 29, 2019— Concept Medical Inc. announced that it has been granted FDA Breakthrough Device designation for the company's MagicTouch arteriovenous fistula (AVF) sirolimus-coated balloon (SCB) catheter for the treatment of stenotic lesions of AVFs or AV grafts (AVGs) in hemodialysis treatment of renal failure. SAN CARLOS, Calif., May 6, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA) today announced that the U.S. Food and Drug Administration (FDA) has granted "Breakthrough Device" designation for its . Transcript (PDF - 262KB) On January 17, 2019, the FDA will host a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. KIRKLAND, WA — May 30, 2019 — Resolution Bioscience, Inc., today announced that the Resolution HRD™ liquid biopsy assay has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation FDA Grants Breakthrough Device Designation to Caris Life Sciences' MI ... The annual number of breakthrough designations finally moved into triple figures in 2019, when FDA granted the status to 138 products. The Breakthrough Device designation basically allows companies to benefit from additional FDA input as they work to validate the safety and efficacy of their devices during premarket development, as well as during the submission process, and then expedited review once the submission for the device is filed. With the breakthrough device designation granted in . It indicates, "Click to perform a search". 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 . FDA Grants Breakthrough Device Designation to Anumana's ECG Pulmonary ... Beta Bionics Receives FDA Breakthrough Device Designation Cognoa Receives FDA Breakthrough Designations for Autism Diagnostic and ... The FDA Breakthrough program provides a breakthrough designation for medical devices. He is using an in vitro model to test the electrical stimulation technique that BioPrax™ employs to treat infections. This is Anumana's second technology to receive FDA Breakthrough Device Designation. The letter F. A stylized bird with . Between 13 December 2016 (the date of BDP's inception) 4 and 31 December 2018, the FDA granted breakthrough designation to 84 devices. FDA Grants Breakthrough Device Designation to Liquid Biopsy Liver ... FDA Grants Breakthrough Device Status: iLet Bionic Pancreas - JDRF Garwood Medical Devices granted FDA 'Breakthrough Devices' designation ... According to a news release, Selution SLR was the first drug-eluting balloon (DEB) to garner FDA breakthrough device designation, first in March 2019, then September 2019, for below-the-knee (BTK) indications in peripheral artery disease (PAD). DUBLIN, Oct. 08, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA). DUBLIN, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device (LVAD) for patients with advanced heart failure, currently in development. "The FDA breakthrough device designation for the MI Transcriptome companion diagnostic assay is a significant step in advancing precision cancer care for individuals with specific genetic profiles who could benefit from targeted treatment options," says W. Michael . Miniature and minimally invasive, the interatrial shunt relieves increased left atrial pressure . The FDA also stipulates that the device must represent a "breakthrough" technology. Brian Tucker. A magnifying glass. FDA Grants Breakthrough Device Designation to Natera's Signatera Test