Regulatory/Legal
Sep 21, 2015
Covidien Defibrillation Electrodes A recall was initiated in September 2014 for Covidien defibrillation electrodes and electrodes made by Covidien and...
Sep 17, 2015
OriGen VV13F Reinforced Dual Lumen ECMO Catheters OriGen Biomedical announced a recall in March 2015 for one lot of the OriGen 51 VV13F Reinforced Dual...
Sep 17, 2015
HVAD HeartWare's HVAD Ventricular Assist Device has been the subject of a number of recent recalls, described in a June 2015 company release. The HVAD is...
Sep 17, 2015
Is Robert Califf, nominated to be FDA commissioner, too close to industry? Jim Dickinson By nominating cardiologist Robert M. Califf to be FDA’s next...
Sep 14, 2015
OxyTote A Class I recall of the OxyTOTE Portable Oxygen Unit from the Western/Scott Fetzer Company was initiated in January 2015 because the oxygen...
Sep 14, 2015
For the most part, medical devices treat diseases, improve pain, and make patients feel better. But in a few instances, devices have experienced malfunctions...
Sep 10, 2015
A midpoint review of the Medical Device Single Audit Program (MDSAP) pilot shows that while the initiative is meeting or is on track to hit many of its goals,...
Sep 03, 2015
MD+DI readers got a chance to rate FDA on several criteria. They were harsher on the agency than our regulatory experts, but you may be surprised by the issue...
Sep 02, 2015
Two studies point to the need for a more efficient, informed medical device approval process at FDA. Jim Dickinson Their pedigrees and their scholarship...
Sep 01, 2015
Medical device makers that have facilities outside the United States and use foreign suppliers are still being scrutinized by FDA. An expert weighs in on the...