FDA clears WellDoc's non-RX version of BlueStar, its mobile diabetes management tool

By Heather Mack
12:35 pm

The US Food and Drug Administration has given the green light for a non-prescription version of BlueStar, WellDoc’s mobile diabetes management platform.

Through this 510(k) class II clearance, WellDoc will now offer BlueStar and BlueStar Rx, allowing the company to offer the product through more channels. Both versions analyze diabetes data entered by the patient, comparing past data trends to form personalized guidance and creating a summary of curated data analytics to the healthcare team for clinical decision support, but the non-prescription version will not feature the insulin calculator that the full version does.

WellDoc President and CEO Kevin McRaith called the clearance a “significant milestone” for WellDoc, as the non-prescription version will be easier to integrate into health plans.

“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 enaged,” McRaith said in a statement.

Nick Harsh, WellDoc’s Head of Market Access, echoed McRaith’s comments on the market opportunities the non-prescription version presents.

“We feel the optionality of multiple versions now greatly enhances the business potential for BlueStar by allowing more options for payers to adopt it and expand access across their networks,” Harsh said in a statement. “This clearance provides payers broader opportunities to use a proven tool that has demonstrated significant clinical outcomes to help better serve their adult members living with type 2 diabetes.

This new iteration of the BlueStar platform comes just a month after WellDoc received FDA clearance for the wireless integration of BlueStar with Johnson and Johnson subsidiary LifeScan’s blood glucose monitoring system. Using blood glucose data from OneTouch, BlueStar’s platform identifies trends and patterns, sending information to the user’s healthcare team while offering the user individualized feedback in real time. It also offers virtual coaching based on their specific care plan, and the whole system works with the OneTouch Reveal mobile app.

Earlier this month, WellDoc also announced a partnership with the American Association of Diabetes Educators (AADE), a professional membership organization of over 14,000 educators. With that partnership, the BlueStar system began incorporating AADE’s educational content into the platform. 


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