Ottawa-based start-up Realize Medical Inc. reported U.S. FDA clearance of virtual reality (VR) surgical planning software to help physicians create and share complex patient anatomy from CTs and MRIs in an immersive 3D environment. Company CEO Justin Sutherland told BioWorld clearance of the Elucis platform “is a crucial milestone” that will benefit hospitals and his company well into the future.
Abk Biomedical Inc. has completed an oversubscribed $30 million series C funding round to support IDE approval for Eye90 microspheres designed to improve outcomes for patients with liver cancer. The departure point for the technology’s development is U.S. FDA-cleared Y90 technology such as Boston Scientific’s Therasphere and Sir-Spheres developed by Sydney, Australia-based Sirtex Medical Ltd. “They are the only radioembolization microspheres on the market and that is the clinical space in which we will be submitting our IDE application,” Abk chief business officer Gary Donofrio told BioWorld. “Hopefully we’ll get approvals for the pivotal study and eventually to market in that space. It’s going to be great to be able to innovate and improve on what’s already been done there.”
Cardiai Inc. has developed a small, portable monitor that continuously measures patients’ blood pressure (BP) at regular intervals for up to seven days, well beyond the single measurements historically done in a doctor’s office.
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.
Advanced manufacturing company Linamar Corp. has created Linamar Medtech to leverage its skills in precision manufacturing in the medical device and components space. The new venture, which will operate as a separate division under the Linamar umbrella, builds on recent programs producing a range of products, including ventilator systems and parts, part of the COVID-19 pandemic response.
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.