Theradaptive Inc. has received an FDA breakthrough medical device (BMD) designation for its Osteo-Adapt SP spinal fusion implant for transforaminal lumbar interbody fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. Under the program Theradaptive will enjoy priority review for its spinal bone growth implant and interactive advice for continued development as well as clinical trial protocols during premarket review.
TORONTO – Opsens Inc. has successfully treated 20 patients in the first-in-human study employing a new surgical guidewire to improve procedural workflow during transcatheter aortic valve replacement (TAVR). According to Opsens CEO Louis Laflamme, the Savvywire will be the first guidewire to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.
TORONTO – Koios Medical Inc. has received Health Canada approval for its DS Smart Ultrasound decision support software, which the company said accurately interprets breast ultrasound examinations. Company CEO Chad McClennan told BioWorld greater accuracy will provide early cancer detection rates, while reducing costly false positives and unnecessary biopsies.
TORONTO – Despite high tech costs and tight public sector budgeting, COVID-19 has driven Canadian procurement offices to echo a sentiment uttered by average Canadians, “Damn the costs. Give us something that really works.”
TORONTO – Oncocyte Corp. launched Determaio, an immunotherapy response prediction test it said is “the first to comprehensively assess the tumor microenvironment.” This is important because of how smart cancer cells are in that microenvironment, Oncocyte CEO Ronnie Andrews told BioWorld, commandeering natural tissue repair biology and condensing immunological T cells so they back off attacking cancerous tissue.
TORONTO - Medtronic Canada ULC, a subsidiary of Dublin-based Medtronic plc, has launched what it calls the “the first dedicated robotic assisted spine surgery platform in Canada.” The Mazor integrates surgical planning, workflow and execution by combining navigation and robotic technologies.
TORONTO – Trillium Health Partners has received a C$1 million (US$810,000) grant from TD Bank Group to help accelerate the use of artificial intelligence (AI) at a newly developed health care lab. The AI Deployment and Evaluation (AIDE) lab will determine if machine learning models developed by industry and academia work well outside the data sets upon which they were trained.
TORONTO – Imaging company Moleculight Inc. has launched a new point-of-care, wound imaging platform intended for multiple U.S. health care settings and has also inked a deal with a U.S. distributor to ensure it gets there.
TORONTO – Pathway Medical Inc. has raised C$1.6 million (US$1.3 million) in an oversubscribed funding round to expand its evidence-based clinical decision support platform and deliver an enterprise version of its point-of-care technology. The current mobile app uses natural language processing and machine learning to give doctors evidence-based answers to questions on patient diagnosis and treatment.
TORONTO – Radialis Medical Inc. has submitted FDA premarket notification for a positron emission tomography system (PET) that targets specific organs for low dose imaging and may be flexible enough to assess many different diseases. The Radialis PET camera is under clinical investigation at Toronto’s University Health Network and Princess Margaret Cancer Center for its ability to assess anomalies in breast cancer.
