Archive for October 2020
J&J’s Biosense Webster gets FDA Nod for Ablation Catheter for Atrial Fibrillation
Johnson & Johnson Medical Devices Companies today announced the United States Food and Drug Administration (FDA) approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH SF Ablation Catheter for the treatment of persistent atrial fibrillation (persistent AF). The approval is based on results of a prospective, multi-center study (PRECEPT) which met primary safety and effectiveness endpoints and…
Read MoreSimplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA
Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, today announced U.S. Food and Drug Administration (FDA) Approval for the Simplify Disc Pre-Market Application (PMA) for 1-level indications. Simplify Disc achieved superiority to the fusion control on the composite primary endpoint. David Hovda, President and CEO…
Read MoreFDA Grants GI Windows Medical Breakthrough Device Designation for Magnetic Anastomosis Technology
GI Windows Medical Corp, a clinical-stage, privately-held medical device company pioneering new advancements in anastomosis technology announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the self-forming magnetic compression anastomosis device indicated for small bowel end to end anastomosis for ileostomy reversal or tissue resection. The Breakthrough Devices Program is…
Read More