Page 5 - Breakthrough Device Program News Today

Medtronic Receives FDA Breakthrough Designation for the Emprint Ablation Catheter Kit Minimally Invasive Option Has Potential to Provide Long-Term Management of Lung Malignancies While Protecting Lung Function Medtronic plc the global leader in medical technology, today announced it has received Breakthrough Device Designation status from the U.S. Food and Drug Administration for the Emprint™ ablation catheter kit an investigational device not yet approved or cleared in the United States . Th...

Quadrant Biosciences Receives Breakthrough Device Designation for Novel Autism Saliva Test News provided by Share this article Share this article SYRACUSE, N.Y., April 19, 2021 /PRNewswire/ -- Quadrant Biosciences Inc., a developer of novel molecular diagnostic tools, has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its innovative Clarifi ASD® autism saliva test. Clarifi ASD is indicated f...

Share this article Share this article DURHAM, N.C., March 17, 2021 /PRNewswire/ -- Sparta Biomedical Inc., a developer of orthopedic solutions, today announced that its SBM-01 Biomimetic Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). SBM-01 is intended to replace damaged knee cartilage in patients having single or multiple chondral or osteochondral defects in the knee. The Breakthrough Device Program is designed to accelerate patient...

Novel cartilage regenerative product, Chondro3 is a biomimetic graft for osteochondral lesions The Company's second FDA Breakthrough Device designation granted in 2021 Locate Bio, an orthobiologics

Share this article MONTREAL, Feb. 8, 2021 /PRNewswire/ - Puzzle Medical Devices Inc., ( www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain medical devices that have the potential to provide more effective treatment for life-threatening or...

Financial Institutions, Inc. Schedules Fourth Quarter and Full Year 2020 Earnings Release and Conference Call Financial Institutions, Inc. Schedules Fourth Quarter and Full Year 2020 Earnings Release and Conference Call WARSAW, N.Y., Jan. 06, 2021 — Financial Institutions, Inc. (NASDAQ:FISI) (the “Company”), the parent company of Five Star Bank, SDN Insurance Agency, LLC (“SDN”), Courier Capital, LLC (“Courier Capital”) and HNP Capital, LLC (“HNP Capital”), will release result...

Kofax Announces ReadSoft Online Integration with Microsoft Dynamics 365 for Invoice & Accounts Payable Automation Kofax Announces ReadSoft Online Integration with Microsoft Dynamics 365 for Invoice & Accounts Payable Automation Kofax, a leading supplier of intelligent automation software for digital workflow transformation, today announces the integration of ReadSoft Online, its software-as-a-service (SaaS) solution for invoice data extraction and accounts payable automation, with the Microsoft...

18 dicembre 2020 06:30 Fonte: Adnkronos #salute-e-benessere TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ -- Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes "The MagicTouch SCB Sirolimus Coa...

(1) TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ -- Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes "The MagicTouch SCB Sirolimus Coated Balloon Catheter is indicated for percutaneous trans...