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The second criterion for establishing a device category, at 419.66(c)(2), provides that CMS determines either of the following: (1) that a device to be included in the category has demonstrated that it will substantially improve the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body part compared to the benefits of a device or devices in a previously established category or other available treatment

This effective concentration is actually higher than the previously reported Km in cell-free assays ( 33 )

Current data are insufficient to establish definitive conclusions regarding translational relevance, safety parameters, or functional outcomes