Welldoc announced today that it received another FDA 510(k) clearance for its BlueStar diabetes treatment platform.
Columbia, Maryland-based Welldoc’s new clearance for BlueStar — the ninth in total — expands insulin dosing support to most types of insulin, including bolus and premixed insulin titration for type 2 diabetes.
Previous FDA clearances include in June 2020 when the FDA cleared the BlueStar Insulin Adjustment Program for basal insulin titration. It also holds clearances for advanced AI capabilities and enhanced product features, according to a news release.
BlueStar guides individuals through living with diabetes by integrating personalized, real-time and actionable insights into their daily lives, enabling improved health and outcomes, with AI leveraging health data to bring many dimensions of diabetes care into one platform.
Welldoc CMO Dr. Mansur Shomali said in the release that the new offering will help clinicians optimize insulin management and reduce the burden of care coordination.
“Our platform holistically integrates complex insulin management and the many factors that influence a person’s health. By translating the best of medical science into a digital health solution, clinicians will be able to manage insulin adjustment in a safe, effective, and efficient manner, while simultaneously caring for the whole person,” Welldoc president & CEO Kevin McRaith said. “This clearance is yet another validation of the impact and significance of our digital health offering for those living with diabetes.”
Earlier this year, Welldoc expanded an agreement with Dexcom to use the BlueStar system and offer guidance to individuals through the self-management of diabetes, while Dexcom’s G6 continuous glucose monitoring (CGM) system measures glucose levels just beneath the skin’s surface and wirelessly transmits data every five minutes.