Welldoc announced today that it received the 10th FDA 510(k) clearance for its BlueStar diabetes digital health solution.
The latest regulatory nod enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. Columbia, Maryland-based Welldoc aims to make this enhanced functionality available commercially in 2024.
“The receipt of our 10th 510(k) clearance is another milestone demonstrating Welldoc’s commitment to leading innovation in digital health. Welldoc has achieved a significant level of clinical validation in supporting complex chronic conditions,” said Kevin McRaith, president and CEO of Welldoc. “Insulin dosing is a critical piece to diabetes management, and now, Welldoc’s software has the power to deliver these important data and insights directly into the hands of adults living with diabetes, their caregivers and their healthcare providers.”
Welldoc’s last FDA clearance for BlueStar — its ninth in total — expanded insulin dosing support to most types of insulin. That included bolus and premixed insulin titration for type 2 diabetes. That regulatory victory came in September 2021. 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.
BlueStar, the flagship product from Welldoc, guides individuals through their management of diabetes. It enables self-management of care while enhancing connections to the user’s healthcare team. Welldoc partners with health plans, systems and employers to extend care, improve health and reduce costs.
The platform utilizes AI to leverage health data to bring many dimensions of diabetes care into one platform.