Canada’s health regulator has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). Pfizer submitted documentation related to the BNT162b2 vaccine to Canadian regulators on Oct. 9, 2020. “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” Health Canada explained in a statement. The agency also stressed […]
Health Canada
Canada approves Abbott Freestyle Libre 2 for adults and children
Abbott (NYSE:ABT) announced that Health Canada has approved its FreeStyle Libre 2 continuous glucose monitor for adults and children. The next-generation, wearable, sensor-based CGM technology with real-time alarms is approved for use in adults and children (four years old and up) and will be priced the same as the current FreeStyle Libre system, according to a […]
Canada approves Tandem Diabetes Caree’s advanced hybrid closed-loop insulin pump
Tandem Diabetes Care (NSDQ:TNDM) announced today that Health Canada has approved its t:slim X2 insulin pump with Control-IQ technology. The news comes nearly a year after the U.S. launch of the t:slim X2 with Control-IQ. Get the full story on our sister site Drug Delivery Business News.
Canada to buy 7.6M BD rapid COVID-19 tests
Becton Dickinson (NYSE:BDX) announced that Health Canada authorized its rapid COVID-19 tests and will buy 7.6 million of them. Under interim order, Health Canada authorized BD’s rapid, point-of-care SARS-CoV-2 antigen test for use with the BD Veritor Plus system. The order for 7.6 million tests runs through March 2021 in an effort to support Canada’s planning […]
Report: Canada to buy 7.9M Abbott COVID-19 tests
The Government of Canada announced today that it agreed to buy up to 7.9 million Abbott (NYSE:ABT) ID NOW rapid point-of-care COVID-19 tests. Canadian Minister of Public Services and Procurement Anita Anand, along with Minister of Health Patty Hajdu, announced the agreement for the tests, although the purchase still hinges on Health Canada authorization for the […]
CAE receives Health Canada nod for CAE Air1 ventilator
CAE (NYSE:CAE) announced today that its CAE Air1 ventilator received certification from Health Canada and is set to treat people with COVID-19. Two months ago, the Canadian government issued a contract to CAE to manufacture and supply 10,000 ventilators amid the COVID-19 pandemic. The devices deliver pressure control, volume control and pressure support ventilation using […]
Canada orders 37 million syringes from BD in anticipation of COVID-19 vaccine
Canada reportedly signed a contract to purchase 37 million syringes from Becton Dickinson (NYSE:BDX) in preparation for a potential COVID-19 vaccine. A report in The Record revealed that Public Services & Procurement Minister Anita Anand said the country made a purchase order from the Canadian branch of BD in an effort to make sure Canada is […]
Health Canada authorizes Abbott COVID-19 antibody test
Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19. The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG […]
Abbott’s FreeStyle Libre authorized for hospitalized COVID-19 patients in Canada
Abbott (NYSE:ABT) announced today that Health Canada authorized use of its FreeStyle Libre system in hospital settings for COVID-19 patients. Following the authorization, healthcare workers in Canada can remotely monitor patients’ glucose status and glucose history with the FreeStyle Libre sensor-based glucose monitoring technology. Abbott also intends to donate 3,000 sensors to ensure hospitals have immediate […]
FDA to authorize certain imported respirators for healthcare worker use
The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak. The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on […]
Sequana Medical lands IDE approval for abdominal pump trial
Sequana Medical said it has received investigational device exemption approval from the FDA to conduct a pivotal study of its Alfapump device for patients with recurrent or refractory ascites due to liver cirrhosis. Alfapump is a fully implantable pump designed to continuously remove excess abdominal fluid in patients with liver disease. Zurich-based Sequana has applied to […]