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WellDoc gets FDA OK on therapeutic

Columbia-based digital health technology company WellDoc announced that the U.S. Food and Drug Administration has granted it clearance for a non-prescription version of its BlueStar digital therapeutic. This will allow WellDoc more flexibility in offering the product through additional channels to adults living with Type 2 diabetes, the company said.

“This FDA clearance is a significant milestone for WellDoc,” said Kevin McRaith, WellDoc president & CEO. “We can now integrate BlueStar more seamlessly into the health care ecosystem as we commercialize the product and significantly scale it by working with our existing partners as well as others with which we are actively engaged.”

WellDoc now will offer BlueStar and BlueStar Rx. The non-prescription version will have all the features of BlueStar Rx apart from an insulin calculator. BlueStar Rx will continue to include an insulin calculator for users to access and support their mealtime insulin dosing calculations.


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