Sam Brusco, Associate Editor08.23.23
Welldoc has earned the 11th U.S. Food and Drug Administration (FDA) 510(k) clearance for its BlueStar diabetes digital health solution.
The latest 510(k) allows BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. The feature boosts BlueStar’s digital coaching capabilities, which guide dietary and lifestyle decisions and help people self-manage their diabetes.
According to Welldoc, it’s the first company to receive clearance for a CGM-informed bolus calculator that’s specifical designed for adults managing diabetes with multiple, daily insulin injections. BlueStar gained its 10th FDA clearance last week.
“This 11th 510(k) clearance is a remarkable achievement for Welldoc and demonstrates our steadfast commitment to transforming chronic care. We are dedicated to creating new digital health capabilities which leverage the latest innovations like CGM to develop more connected and personalized solutions for individuals with complex health needs,” Kevin McRaith, president and CEO of Welldoc told the press.
Welldoc’s comprehensive, chronic care platform offers multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, and mental wellbeing. The company partners with health plans, health systems, and employers with the aim of extending care, improving health, and reducing costs.
BlueStar is the company’s flagship product.
“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” said Dr. Grazia Aleppo, a practicing endocrinologist, with the Feinberg School of Medicine at Northwestern University.
The latest 510(k) allows BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. The feature boosts BlueStar’s digital coaching capabilities, which guide dietary and lifestyle decisions and help people self-manage their diabetes.
According to Welldoc, it’s the first company to receive clearance for a CGM-informed bolus calculator that’s specifical designed for adults managing diabetes with multiple, daily insulin injections. BlueStar gained its 10th FDA clearance last week.
“This 11th 510(k) clearance is a remarkable achievement for Welldoc and demonstrates our steadfast commitment to transforming chronic care. We are dedicated to creating new digital health capabilities which leverage the latest innovations like CGM to develop more connected and personalized solutions for individuals with complex health needs,” Kevin McRaith, president and CEO of Welldoc told the press.
Welldoc’s comprehensive, chronic care platform offers multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, and mental wellbeing. The company partners with health plans, health systems, and employers with the aim of extending care, improving health, and reducing costs.
BlueStar is the company’s flagship product.
“With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets,” said Dr. Grazia Aleppo, a practicing endocrinologist, with the Feinberg School of Medicine at Northwestern University.