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The SynchroMed II application provides visual tools, such as flex dosing graphics, and guided workflows, with the goal of simplifying treatment management. Read More
A new IVD application for priority review status should include a justification for how early market availability in the country will result in improved health. Read More
If an accessory request included in a cleared or approved submission is denied, the new accessory type “will be considered to be in the same classification… Read More