WellDoc receives FDA clearance for BlueStar insulin calculator
By HME News Staff
Updated 9:20 AM CDT, Thu August 31, 2023
COLUMBIA, Md. – WellDoc, a provider of digital health chronic care solutions, has received 510(k) clearance from the Food and Drug Administration for its BlueStar diabetes solution. BlueStar provides bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes. Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin. “This 510(k) clearance is a remarkable achievement for Welldoc and demonstrates our steadfast commitment to transforming chronic care,” said Kevin mcRaith, president and CEO. “We are dedicated to creating new digital health capabilities which leverage the latest innovations like CGM to develop more connected and personalized solutions for individuals with complex health needs.”
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