Health Canada approved a device which Wayne, Pa.-based Teleflex Inc. described as the first commercially available biomechanical vascular device designed to close large holes in the femoral artery during endovascular catheterization procedures.

Canada’s federally-funded Digital Technology Supercluster is joining with industry to invest CA$17.8 million (US$13.9 million) in an artificial intelligence (AI)-powered technologies program to advance personalized treatment for patients with cancer.

Much of the question of FDA regulation of artificial intelligence (AI) and machine learning (ML) is seen as revolving around changes to the statute, but that does not mean the FDA and other agencies are in wait-and-see mode. Representatives of both the FDA and Health Canada said on a March 22 webinar that guidances related to these algorithms will be posted later this year, thus opening the door to a more predictable premarket path for these products.

Vena Medical Inc. received Health Canada approval for a device that combines two neurovascular catheters that typically work separately to remove clots from the brains of people who have suffered stroke.

New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.

A needle-free injection system for patients with diabetes developed by Nugen Medical Devices Inc. has been approved for use in 40 countries but until now has yet to crack the North American market. Nugen said it is now gearing up for FDA and Mexican approval of the Nugen MD needle-free injector following Health Canada’s approval of the system less than a month after the Toronto med tech went public in late 2021.

As attention turns to new drugs that can address the growing burden of Alzheimer’s disease (AD) in an aging global population, Retispec Inc. has developed a noninvasive test that may be able to detect early signs of the neurodegenerative disease decades before clinical symptoms appear – and when therapies appear to be most helpful in slowing or reversing Alzheimer’s. By using “off-the-shelf” ophthalmic equipment, the Toronto-based company’s solution enables assessment by optometrists or other eye professionals during a standard eye exam.

TORONTO – Hyivy Health Inc. has secured CA$1.1 million (US$888,000) in pre-seed funding to manufacture, test and obtain medical device approval for a women’s pelvic rehabilitation platform and to explore its use for relieving pelvic pain during clinical trials this summer.