Sam Brusco, Associate Editor08.15.23
Welldoc, a digital health company focused on chronic care, has received its tenth U.S. Food and Drug Administration (FDA) 510(k) clearance for its BlueStar diabetes digital health solution.
The clearance enables BlueStar to use connected insulin dosing data for personalized bolus insulin dosing recommendations. According to Welldoc, the enhanced functionality will be released 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,” Kevin McRaith, president and CEO of Welldoc, told the press. “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 BlueStar digital health tool guides patients through living with diabetes by letting them self-manage their care while enhancing connections to their healthcare team. The company partners with health plans, health systems, and employers in an aim to extend care, improve health, and reduce costs.
Welldoc has also built an intellectual property (IP) portfolio of 40 patents for its advanced artificial intelligence (AI) and first-in-class tech. The company currently has over 70 clinical publications.
The clearance enables BlueStar to use connected insulin dosing data for personalized bolus insulin dosing recommendations. According to Welldoc, the enhanced functionality will be released 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,” Kevin McRaith, president and CEO of Welldoc, told the press. “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 BlueStar digital health tool guides patients through living with diabetes by letting them self-manage their care while enhancing connections to their healthcare team. The company partners with health plans, health systems, and employers in an aim to extend care, improve health, and reduce costs.
Welldoc has also built an intellectual property (IP) portfolio of 40 patents for its advanced artificial intelligence (AI) and first-in-class tech. The company currently has over 70 clinical publications.