Page 10 - Devices Program News Today

To print this article, all you need is to be registered or login on Mondaq.com. What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency ...

(1) PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise Ultrasound Renal Denervation System (the "Paradise System") demonstrated positive results in the RADIANCE-HTN TRIO ("TRIO") study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately resp...

Share this article Share this article PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise™ Ultrasound Renal Denervation System (the "Paradise System") demonstrated positive results in the RADIANCE-HTN TRIO ("TRIO") study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled ...