Digital health leader WellDoc has received FDA 510(k) class II clearance for a non-prescription version of the BlueStar® digital therapeutic diabetes management platform. This news comes on the heels of two other significant recent announcements for BlueStar®: the FDA’s clearance of the wireless integration of LifeScan’s OneTouch Verio Flex® blood glucose monitoring system with BlueStar®, and plans to incorporate the American Association of Diabetes Educators’ (AADE) curriculum in the BlueStar® digital therapeutic platform. The AADE/WellDoc partnership marks the first time AADE has collaborated with an organization to provide its curriculum in a consumer-friendly digital format.
FDA 510(k) Clearance Details
As part of the FDA 510(k) class II clearance, WellDoc will offer BlueStar® and BlueStar® Rx. The non-prescription version will have all the first-in-class 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. Additionally, this clearance allows BlueStar’s easy integration into health plan systems.
This therapeutic is designed to fill the support gap between patients and providers during the 8700 hours that individuals live their lives outside the healthcare system each year. WellDoc has a proven track record of contributing published, peer-reviewed clinical evidence of a 1.7 to 2.0 point AIC reduction and has presented real-world patient engagement and clinical outcomes at important scientific meetings.
“This FDA clearance is a significant milestone for WellDoc,” said Kevin McRaith, WellDoc President & CEO in a statement. “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.”