The first Neuralink clinical trials outside the US will take place in Canada. Neuralink has secured Health Canada's approval to launch human trials in the country, with the Toronto Western Hospital being the "first and exclusive surgical site" for the procedure. The company first opened its Canadian patient registry in March this year, but now it's actively looking for potential participants. "Recruitment is now open," it has announced on X. Under the CAN-PRIME study, Neuralink will embed its implant in the brain of the participant so that it can interpret their neural activity.

Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as a medical device, cybersecurity, medical device interoperability, wireless medical devices, mobile medical apps and telemedicine. To meet this goal, Health Canada established the Digital Health Division under the Medical Devices Bureau and has been increasing its efforts to build in-house expertise. On October 27, 2021, Health Canada, the US Food and Drug Administration (FDA), and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) jointly published the Good Machine Learning Practice for Medical Device Development: Guiding Principles. The document consists of 10 guiding principles to help promote safe, effective, and high-quality use of artificial intelligence and machine learning (AI/ML) in medical devices.

The U.S. Food and Drug Administration recently partnered with Health Canada and the UK's Medicines and Healthcare products Regulatory Agency to issue guiding principles to align efforts and standards for artificial intelligence and machine learning medical device development in health care. "The FDA believes that artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day," said Jim McKinney, public affairs specialist at the FDA, in an email to The Well News. McKinney said the 10 guiding principles grew out of collaborative discussions with Health Canada and MHRA, and learning from several sectors that applied AI and ML technologies for years and have developed good practices that can be readily applied to the medical device industry. Evidence from published information, expert and other public perspectives and review experience was used to develop the guiding principles that will be used by the agency to lay the foundation for the development of Good Machine Learning Practice, which will unify international efforts for medical device development. Over the past decade the FDA has reviewed and authorized a growing number of devices legally marketed with machine learning and expects this trend to continue.

Venus Bliss is cleared by the FDA and licensed by Health Canada for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less, with the diode laser applicators. The (MP)2 applicator is cleared by the FDA for temporary reduction in the appearance of cellulite, and licensed by Health Canada for temporary increase of skin tightening, temporary circumferential reduction, and temporary cellulite reduction. Venus Bliss has CE Mark as a non-invasive medical aesthetic device enabling a comprehensive approach leading to body contouring, addressing fat reduction, skin tightening, circumference reduction, and cellulite reduction. Venus Versa is cleared by the FDA, licensed by Health Canada, and has CE Mark as a multi-application device intended to be used in aesthetic and cosmetic procedures. The SR515 and SR580 applicators are cleared by the FDA, licensed by Health Canada, and have CE Mark for the treatment of benign pigmented epidermal and cutaneous lesions and treatment of benign cutaneous vascular lesions.