Axonics Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

Posted in Medical Device by Medtech[y] Staff

November 15, 2019 • 2 min read

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM System...

Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT Outcomes Trial

Posted in Biotech by Medtech[y] Staff

November 14, 2019 • 2 min read

​Amarin Corporation plc (NASDAQ: AMRN) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa (icosapent ethyl)...

Nuvectra Continuing to Support Current Patients with the Algovita Implant as Company Voluntarily Files for Chapter 11

Posted in Medical Device by Medtech[y] Staff

November 14, 2019 • 2 min read

Nuvectra Corporation (NASDAQ: NVTR) , a neurostimulation medical device company, today announced that it has elected to file a voluntary petition for reorganization under Chapter 11 of the United States Bankruptcy Code in the U.S. Bankruptcy Court for the Eastern District of Texas (the “Court”). ...