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The SCOUT MD TM Surgical Guidance System has a Breakthrough Device designation and marketing authorization from FDA for the indication covered by the Breakthrough Device designation (as explained in more detail of the newness criterion) and therefore was not evaluated for substantial clinical improvement

Please discuss these with your health professional first, as some therapies can be harmful or may interact with your child's current medicines

We are actively reviewing coverage pathways for innovative treatments that address unmet medical needs in the ESRD population, including those with FDA Humanitarian Use Device designations

If your B12 level is below 200 pg/mL (picograms per milliliter), you're considered to have a deficiency