The Food and Drug Administration has given 510(k) class II clearance to WellDoc for the non-prescription version of its BlueStar digital therapeutic, a mobile app that enables adults living with Type 2 diabetes to better manage the disease.
The digital health vendor is hoping the FDA’s approval will increase the opportunities for health insurers to adopt BlueStar and expand access to the tool across their networks.
“A prescription was required for BlueStar previously, and so we submitted a 510(k) to make that prescription optional,” says Kevin McRaith, president and CEO of WellDoc. “We had quite a dialogue with the FDA. As it turns out, we’re going to have one product now that we call BlueStar Rx which is prescription and that has a feature called an insulin calculator. And we’re going to turn that feature off to allow no prescription to be needed.”
According to McRaith, the non-prescription version of BlueStar will have all the features of BlueStar Rx other than the insulin calculator, which helps users with mealtime insulin dosing calculations. He contends that his company’s products have demonstrated significant clinical outcomes for Type 2 diabetic patients, including evidence of a 1.7 to 2.0 point A1C reduction published in peer-reviewed journals.
“It’s software that’s an app on a smartphone or tablet, but we also have a web version,” adds McRaith. “In the past, you needed a prescription in order to unlock the app. What the 510(k) clearance does is it allows us to do is make the tool available in the iTunes and Google Play app stores so patients can download it without a prescription. But we’re not going to do that right away because our current path is through Johnson & Johnson, Samsung and other partners we’re having discussions with.”
Payment for BlueStar is through health plans, pharmacy benefits management programs and large employers, notes McRaith. “They would be the ones to cover the costs of the product—patients are not paying through the app stores currently.”
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