FDA clears non-prescription Type 2 diabetes digital therapeutic

FDA clears non-prescription Type 2 diabetes digital therapeutic

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The Food and Drug Administration has given 510 class II clearance to WellDoc for the non-prescription version of its BlueStar digital therapeutic, a mobile app that enables adults living with Type 2 diabetes to better manage the disease. The digital health vendor is hoping the FDA’s approval will increase the opportunities for health insurers to adopt BlueStar and expand access to the tool across their networks.