MASSDEVICE ON CALL — Internet and technology giant Google (NSDQ:GOOG) agreed to overhaul its healthcare-related advertising practices after Canadian regulators accused the company of violating privacy laws by using search histories to target users with healthcare-related ads.
Health Canada
Health Canada: MDSAP pilot to last 3 years
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have provided more details about their participation in the international Medical Device Single Audit Program (MDSAP) pilot set to begin in 2014 in Canada, the US, Brazil and Australia.
Health Canada to make medical device clinical trial data publicly available
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have begun making some information on medical device clinical trials available upon request in an effort to boost public access to such data.
Health Canada’s new policy entails sharing information including:
Health Canada: MDSAP pilot to last 3 years
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have provided more details about their participation in the international Medical Device Single Audit Program (MDSAP) pilot set to begin in 2014 in Canada, the US, Brazil and Australia.
Changes to Health Canada’s list of recognized standards
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Canada have added 11 new items to their list of recognized standards, removed six and amended another 27.
Standards newly recognized by Health Canada include IEC and ISO standards covering various electrical medical device components, implantable devices and IVDs.
Medtronic recalls dilation catheters over labeling issue
Health Canada switching to electronic delivery of medical device licenses
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulator Health Canada plans to issue only electronic versions of new and amended Medical Device Establishment Licenses (MDEL) and Medical Device Licenses (MDL) starting November 1, 2013.
According to an email from Health Canada’s Medical Devices Bureau, no more hard copies of new or amended licenses will be sent out to medical device manufacturers in order to boost process efficiencies at the regulator.
AngioDynamics lands Health Canada nod for Celerity system
AngioDynamics (NSDQ:ANGO) said its Canadian distribution partner won approval north of the border to market its Celerity tip location system for peripherally inserted central catheters.
Canada green-lights InSightec’s ablation system
Canadian healthcare regulators approved InSightec‘s ExAblate ultrasound system, clearing the device for use against 2 different diseases. Health Canada granted ExAblate indication to break up benign uterine tumors and to alleviate painful symptoms of metastatic bone tumors.
Natus launches electro-diagnostic system in the U.S., Canada
Natus Medical (NSDQ:BABY) landed regulatory wins from the FDA and Health Canada for its UltraPro S100 EMG, a new electro-diagnostic system designed to monitor a patient’s nervous and muscular systems.
AngioDynamics wins clearances in the U.S., Canada
AngioDynamics (NSDQ:ANGO) celebrated 2 regulatory wins this week, an FDA 510(k) clearance for its Xcela Plus Port family and a nod from Canadian regulators for its Smart Port Power-Injectable Ports.