Page 27 - Breakthrough Devices Program News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Shoshanna Solomon is The Times of Israel's Startups and Business reporter The technology developed by IceCure Medical Ltd. destroys tumors by freezing them in a minimally invasive procedure with no surgery or hospitalization requirement (Courtesy) IceCure Medical, an Israel-based maker of tumor-freezing technology, said Sunday that it had received notification from the US Food and Drug Administration recognizing its ProSense product as a “breakthrough device” to freeze tumors in a number of medical conditions including breast cancer. The breakthrough devices recognition is given by the F...

Share this article Share this article PORTLAND, Ore., Feb. 23, 2021 /PRNewswire/ -- Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR ® heart failure management system. The system uses clinically tested algorithms to detect the risk of decompensation at home in patients who have been previously hospitalized for heart failure. Inovise Medical, Inc. Michael Mirro, MD, Director of the Parkview Mirro Center for Research and Innovation, and Clinical Professor of Medicine at Indiana University, commented, "This ...

With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices By Mark Durivage, Quality Systems Compliance LLC The FDA’s Center for Devices and Radiological Health (CDRH) releasedthe Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. The two-month delay is due to the expected time to “operationalize” the program, which is a voluntary program applicable to “certain medical devices and devic...

WOLHUSEN, Switzerland--(BUSINESS WIRE)--Geistlich Pharma, a Swiss developer of biomaterials for regenerative therapies in orthopedics, announced that the Chondro-Gide® articular cartilage cover has been granted a Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration. Chondro-Gide® is a col...

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