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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 . The … Minimally Invasive Option Has Potential to Provide Long-Term Management of Lung Malignancies ...

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 for use in assessing the likelihood that a child has autism spectrum disorder (ASD) based on an evalu...

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 access to promising technologies that have the potential to provide more effective treatments for d...

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 irreversibly debilitating diseases or conditions, including a prioritized review of market approval...