Vitacore receives approval in Canada for its custom-fit CPAP mask
By HME News Staff
Updated 10:54 AM CDT, Tue May 26, 2026
VANCOUVER, British Columbia – Vitacore has received a Medical Device License (MDL) from Health Canada for FormFit, a fully custom-fit medical-grade silicone CPAP mask, the first of its kind, the company says. With regulatory approval secured, Vitacore is officially launching FormFit across Canada, direct-to-consumer at vitacore.com/formfit and through participating sleep clinics and health care providers nationwide. “One of the fundamental problems in CPAP therapy is that we’ve been trying to fit an extremely diverse range of facial shapes into a small number of generic mask designs,” said Mikhail Moore, president of Vitacore. “The medical device industry has long assumed that mass production and true personalization are incompatible. FormFit proves they are not. We've built a platform that translates each patient's unique anatomy into a manufactured, medical-grade product with no compromises, no generic shells, no 'best available size.' FormFit is the first product on this platform, and I believe it represents the future of how personalized medical devices will be designed and built.” Vitacore says its proprietary technology converts a short smartphone facial scan into a high-resolution 3D facial model, which is then used to produce a precisely fitted mask that is manufactured in Canada. FormFit is compatible with CPAP, APAP and BiPAP therapy devices. With the Canadian launch underway, Vitacore is also preparing a submission to the U.S. Food and Drug Administration (FDA).
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