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Health Canada

Health Canada licenses Medtronic Symplicity Spyral renal denervation system

March 19, 2024 By Sean Whooley

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 […]

Filed Under: Cardiovascular, Regulatory/Compliance Tagged With: Health Canada, Medtronic

Health Canada licenses Medtronic Guardian 4 CGM sensor for use with MiniMed 780G

May 4, 2023 By Sean Whooley

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. […]

Filed Under: Business/Financial News, Diabetes, Drug Pumps, Drug-Device Combinations, Health Technology, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: Health Canada, Medtronic

Axonics receives Health Canada approval for rechargeable sacral neuromod

December 13, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Implants, Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: Axonics, Axonics Modulation Technologies, FDA, Health Canada

Health Canada licenses Medtronic extended-wear infusion set for insulin delivery

December 12, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diabetes, Drug Pumps, Drug-Device Combinations, Regulatory/Compliance Tagged With: Health Canada, Medtronic

Health Canada licenses Medtronic next-gen MiniMed 780G insulin pump

November 1, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diabetes, Drug Pumps, Drug-Device Combinations, Health Technology, Patient Monitoring, Regulatory/Compliance Tagged With: Health Canada, Medtronic

Abbott launches digital health app for neurostimulation in Canada

July 26, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Digital Health, Featured, Health Technology, Neurological, Neuromodulation/Neurostimulation, News Well, Pain Management, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: Abbott, Health Canada

Health Canada licenses Medtronic’s GI Genius endoscopy module for colonoscopy

November 30, 2021 By Sean Whooley

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 […]

Filed Under: Endoscopic, Health Technology, Imaging, Software / IT Tagged With: Health Canada, Medtronic

Abbott wins CE mark for Amplatzer steerable delivery sheath

June 7, 2021 By Sean Whooley

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 […]

Filed Under: Cardiovascular, Featured, Regulatory/Compliance, Structural Heart, Vascular Tagged With: Abbott, CE Mark, Health Canada

Canada approves J&J Vision’s drug-eluting contact lens

April 27, 2021 By Sean Whooley

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 […]

Filed Under: Drug-Device Combinations, Optical/Ophthalmic, Pharmaceutical, Regulatory/Compliance Tagged With: Health Canada, Johnson & Johnson, Johnson & Johnson Vision

Medtronic gains Health Canada nod for Micra AV pacemaker

December 22, 2020 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Regulatory/Compliance, Structural Heart Tagged With: Health Canada, Medtronic

Health Canada gives Edwards’ Sapien 3 TAVR expanded use nod

December 18, 2020 By Nancy Crotti

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Featured, Regulatory/Compliance, Replacement Heart Valves Tagged With: Edwards Lifesciences, Health Canada

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