Sorin Group (BIT:SRN) said today that it won approval from Health Canada for its Perceval sutureless aortic valve replacement. The valve, which is designed to hold itself in place with a self-anchoring frame, is under review at the FDA now that Sorin has a U.S. investigational device exemption trial under its belt, the company said. “Sorin is […]
April 9, 2015 by Brad Perriello
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have issued a draft notice on plans to implement a national Unique Device Identification (UDI) system based solely on guidelines developed by the International Medical Device Regulators Forum (IMDRF).