News & Updates

WellDoc Receives FDA 510(k) Clearance to Offer a Non-Prescription Version of BlueStar® Digital Therapeutic for Type 2 Diabetes

January 19, 2017

Enhances Company’s Ability to Expand Access to BlueStar® Across the Healthcare Ecosystem

Columbia, Maryland, January 19, 2017 – Digital health leader WellDoc announced today that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) class II clearance for a nonprescription version of the BlueStar® digital therapeutic. This BlueStar® option will allow WellDoc more  flexibility in offering the product through additional channels to adults living with type 2 diabetes.

“This FDA clearance is a significant milestone for WellDoc,” said Kevin McRaith, WellDoc President &  CEO. “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.”

Based on this 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.

“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,” said  WellDoc’s Head of Market Access Nick Harsh. “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 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.

About WellDoc®

WellDoc is a digital health technology company that develops mobile solutions to drive behavioral and clinical change in chronic disease. WellDoc’s goal is to improve patient self-management and help physicians overcome gaps in the delivery system to improve clinical outcomes and decrease cost. WellDoc has commercialized BlueStar®, a digital therapeutic, for adults with type 2 diabetes. 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. BlueStar® is recognized by the ADA on its website as the first and only in the new class of diabetes treatment known as Mobile Prescription Therapy. In a recently published Forbes blog, WellDoc was named among one of five healthcare tech companies to watch in 2016. For more information, visit www.WellDoc.com and www.BlueStarDiabetes.com