Bridge to Life wins Health Canada license, FDA Breakthrough tag
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Duluth, Georgia – November 03, 2026 -- Bridge to Life Ltd. has secured a Health Canada Medical Device License for its VitaSmart HOPE System and an FDA Breakthrough Device Designation for investigational use in donor intestines, widening the commercial reach of its organ perfusion platform in North America.
Health Canada license opens liver transplant centers nationwide
The Canadian license covers hypothermic oxygenated perfusion (HOPE) of donor livers and makes VitaSmart available to transplant centers across Canada. More than 4,000 Canadians are on organ transplant waiting lists, and over 100,000 Americans are waiting in the U.S. Bridge to Life executives attended the Canadian Society of Transplantation Annual Scientific Meeting in Montreal in October as part of the market launch.