Health Canada
Edap shares jump on Health Canada nod for prostate device
August 2014 Medical device recalls | Regulatory news for the week of September 8, 2014
Medical device recalls for August 2014
September 3, 2014 by MassDevice
August Summary
Class I recalls: 244
Class II recalls: 171
Diabetes: Medtronic wins Health Canada nod for enhanced Enlite glucose sensor
Health Canada to follow IMDRF unique device identification framework
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).
Endo Health warned by FDA on AMS pelvic mesh plant | Medtech regulatory news for the week of Apr. 21, 2014
In brief: Health Canada updates medical device license application forms
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have issued updated submission forms for Medical Device License (MDL) applicants.
Health Canada Inspection Report: High CMDR compliance rates for medical device establishment license holders
By Stewart Eisenhart, Emergo Group
Sapheon wins Canadian approval for medical adhesive
Sapheon secured approval from Health Canada for its VenaSeal Sapheon closure system, used in the treatment of varicose veins.
Morrisville, N.C.-based Sapheon develops treatments for vascular disease, its flagship product being the VenaSeal, a medical adhesive which seals blood vessels using a special glue. The company is currently working towards getting pre-market approval from the U.S. FDA.
Diabetes: Echo Therapeutics files for CE Mark approval for Symphony CGM system
Echo Therapeutics (NSDQ:ECTE) said it filed for CE mark approval in the European Union for its Symphony continuous glucose monitoring system.
EndoChoice lands Canadian nod for colonoscope
EndoChoice said it won a marketing license in Canada for its Fuse endoscopy system.
The Fuse endoscope features 3 small cameras that provide a 330-degree view, nearly double the range of typical colonoscopy devices.
The Fuse device won FDA 510(k) clearance in the U.S. in June 2013.