Medtronic announced today that it received a license from Health Canada for its Symplicity Spyral renal denervation (RDN) system. The licensing covers the management of essential hypertension in patients for whomblood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated. Approval in Canada comes […]
Health Canada
Health Canada licenses Medtronic Guardian 4 CGM sensor for use with MiniMed 780G
Medtronic (NYSE:MDT) announced that it received a license from Health Canada for use of its Guardian 4 with the MiniMed 780G. The licensing enables the use of the next-generation continuous glucose monitor sensor with the next-generation automated insulin pump. MiniMed 780G with Guardian 4, an advanced, hybrid closed-loop system, helps users manage type 1 diabetes. […]
Axonics receives Health Canada approval for rechargeable sacral neuromod
Axonics (Nasdaq:AXNX) announced today that Health Canada approved its fourth-generation rechargeable sacral neuromodulation (SNM) system. Irvine, California-based Axonics’ R20 neurostimulator received labeling for a functional life in the body of at least 20 years. It reduces how frequently a patient must recharge their implanted device to once every six to 10 months. The devices charge […]
Health Canada licenses Medtronic extended-wear infusion set for insulin delivery
Medtronic (NYSE:MDT) Canada announced that Health Canada licensed its Medtronic Extended infusion set for insulin pumps. The Medtronic Extended Infusion Set is the first and only infusion set labeled for a wear time of up to seven days. The infusion set for delivering insulin from a pump to the body typically requires changing every two […]
Health Canada licenses Medtronic next-gen MiniMed 780G insulin pump
Medtronic (NYSE:MDT) Canada announced today that Health Canada granted a license to its MiniMed 780G automated insulin delivery system. The company designed its MiniMed 780G advanced hybrid closed-loop insulin pump system to automatically adjust and correct sugars every five minutes. According to Medtronic, it marks the first and only insulin pump system in Canada to […]
Abbott launches digital health app for neurostimulation in Canada
Abbott (NYSE:ABT) announced today that it received Health Canada licensing for its NeuroSphere Virtual Clinic, enabling it to launch the app. The Abbott Park, Illinois–based company designed the remote programming technology — the first of its kind in Canada — with compatibility with Abbott’s suite of neuromodulation technologies, offering the potential to increase access to […]
Health Canada licenses Medtronic’s GI Genius endoscopy module for colonoscopy
Medtronic (NYSE:MDT) announced today that it received Health Canada license for its GI Genius intelligent endoscopy module. The company’s Brampton, Ontario-based Medtronic Canada subsidiary received the license for the computer-aided detection (CADe) system that uses artificial intelligence (AI) to highlight regions of the colon suspected to have visual characteristics consistent with different types of mucosal […]
Abbott wins CE mark for Amplatzer steerable delivery sheath
Abbott (NYSE:ABT) announced today that it received CE mark and Health Canada approval for its Amplatzer steerable delivery sheath. The company touts the Amplatzer sheath as the first steerable delivery sheath to be developed specifically for minimally invasive left atrial appendage (LAA) occlusion (or closure) procedures for patients diagnosed with atrial fibrillation who are at […]
Canada approves J&J Vision’s drug-eluting contact lens
Johnson & Johnson Vision announced today that it received Health Canada approval for its Acuvue Theravision drug-eluting contact lens. Jacksonville, Fla.-based J&J Vision’s Acuvue Theravision with Ketotifen is touted as the first and only vision-correcting contact lens that relieves allergic eye itch through drug delivery. The company received Japanese approval for the lens last month. Get the […]
Medtronic gains Health Canada nod for Micra AV pacemaker
Medtronic Canada (NYSE:MDT) announced that it received a Health Canada license for its Micra AV pacemaker with atrioventricular synchrony. Brampton, Ontario-based Medtronic Canada said in a news release that Micra AV is indicated for treating patients with AV block, making it the first and only Health Canada-licensed leadless pacemaker portfolio. The pacemaker won FDA approval in […]
Health Canada gives Edwards’ Sapien 3 TAVR expanded use nod
Edwards Lifesciences (NYSE:EW) today announced that Health Canada has approved the expanded use of the company’s Sapien 3 and Sapien 3 Ultra transcatheter heart valves to treat patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 valves are the first transcatheter aortic valve replacement (TAVR) systems to […]
