Digital health leader WellDoc announced today that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) class II clearance for a non-prescription version of the BlueStar® digital therapeutic. This BlueStar® option will allow WellDoc more flexibility in offering the product through additional channels to adults living with type 2 diabetes.
“This FDA clearance is a significant milestone for WellDoc,” said Kevin McRaith, WellDoc President & CEO. “We can now integrate BlueStar® more seamlessly into the healthcare 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.”