Health Canada Archives - Medical Design Sourcing

Health Canada licenses Medtronic Symplicity Spyral renal denervation system

The Medtronic Symplicty Spyral RDN system expands inside the renal arteries. It then ablates nerves in the vessel wall to treat hypertension. [Illustration courtesy of Medtronic]Medtronic (NYSE: MDT) + 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 about four months after the company’s landmark FDA approval for Symplicity Spyral in November 2023.

Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure. These nerves can become overactive and contribute to high blood pressure.

After sedat…

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

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]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.

Health Canada licensing comes on the heels of FDA approval for the MiniMed 780G with Guardian 4. The system requires no fingersticks while in SmartGuard mode. It offers meal detection technology, providing automatic adjustments and corrections to sugar levels every five minutes.

Get the full story at our sister site, Drug Delivery Business News.

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 for only one hour.

The previous generation of the device had a recharging interval of once a month for one hour. R20 utilizes the same small 5cc form factor as that device and pairs to the same tined lead and patient remote control.

“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of our development efforts,” said Raymond W. Cohen, CEO of Axonics. “Patients with overactive bladder want efficacy and a long-lived solution to address their chronic condition. The Axonics R20 represents a significant breakthrough for rechargeabl…

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

[Image from Medtronic]Medtronic (NYSE:MDT) Canada announced that Health Canada licensed its Medtronic Extended infusion set for insulin pumps.

The Medtronic Extended Infusion Set represents 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 to three days.

Its availability covers customers using MiniMed 600 and 700 series pumps. Medtronic developed it in partnership with Convatec Infusion Care.

Get the full story at our sister site, Drug Delivery Business News.

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

The next-gen MiniMed 780G system. [Image from Medtronic]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 do so. It also features SmartGuard technology for avoiding highs and lows in blood sugar.

SmartGuard enables users to personalize their glucose goals with an adjustable target setting. The setting — as low as 5.5 mmol/L — comes in lower than any other advanced hybrid closed-loop system, Medtronic said. It helps stabilize blood sugar levels to further improve glucose control.

Get the full story at our sister site, Drug Delivery Business News.

Abbott launches digital health app for neurostimulation in Canada

Abbott (NYSE:ABT) announced today that it received Health Canada licensing for and launched its NeuroSphere Virtual Clinic.

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 optimal treatment for patients living with chronic pain, Parkinson’s disease, or essential tremors who might otherwise have difficulty receiving care from their healthcare provider due to location or being unable to travel to seek care.

Users can receive care anywhere by connecting with their doctor through a secure in-app video chat and an integrated remote programming feature. Clinicians can prescribe new treatment settings remotely to the patient’s neurostimulation device using the clinician programmer app and a new, simple, and secure remote care connection.

In April, the company…

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

[Image from Medtronic]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 abnormalities.

According to a news release, the GI Genius intelligent endoscopy module — which Medtronic touts as compatible with any colonoscope video — provides physicians with a tool to fight against colorectal cancer.

GI Genius uses advanced AI to highlight the presence of possible precancerous lesions with a visual marker in real-time. Advanced algorithms process the colonoscopy images to identify and mark polyp abnormalities, including ones that could otherwise go detected under the observation of the human eye.

…

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 risk of ischemic stroke, according to a news release.

Abbott Park, Ill.-based Abbott designed the sheath for use with its Amplatzer Amulet LAA occluder. The company said the sheath also features bi-directional steering and an auto-lock setting for more accurate alignment with the LAA.

Additionally, the sheath includes a hemostasis valve designed to stabilize blood flow and minimize blood loss during the procedure. Abbott said the new design reduces the need for catheter manipulation or exchanges, thus reducing issues that slow down procedures or cause further blood loss.

M…

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 full story at our sister site, Drug Delivery Business News.

CAE receives Health Canada nod for CAE Air1 ventilator

The CAE Air1 ventilator (CNW Group/CAE INC.)

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 room air or pressured oxygen.

The CAE Air1 ventilator includes an intuitive touchscreen interface and is bundled with on-demand ventilator training, adaptive e-learning modules related to COVID-19 patient management and 24/7 customer support.

Montreal-based CAE said in a news release that it will begin shipping hundreds of CAE Air1 machines to the Canadian government every week.

“Since the beginning of the pandemic, CAE was the first to receive certification from Heal…

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 ready for mass vaccinations if the cure for COVID-19 is discovered. There is no definitive timeline for the delivery of the syringes as of now.

The Record cited Statistics Canada as reporting that more than 38 million people comprise the country’s population, one million more than the total number of syringes agreed upon in the contract. Canada Chief Public Health Officer Theresa Tam said the order represents the “maximum number of Canadians who may wish to be vaccinated,” according to the report.

Currently, Chinese pharmaceutical company CanSino Biologics is collabo…

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 antibody, a protein that the body produces in the late stages of infection and may remain up to months after a person has recovered from the novel coronavirus.

A recent study published in the Journal of Clinical Microbiology found that Abbott’s SARS-CoV-2 IgG antibody test had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptoms began. Abbott has come under scrutiny for the accuracy of one of its COVID-19 molecular diagnostic tests.

The company said it expects to begin shipping antibody tests to Canada this week and intends to distribute 30 million …