COLUMBIA, Md., August 23, 2023 — Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar® . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.
Welldoc’s latest 510(k) enables 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. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes. Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin.
“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,” said Kevin McRaith, President and CEO of Welldoc.
Welldoc’s comprehensive chronic care platform provides multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, and mental wellbeing. Welldoc’s flagship product, BlueStar, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team.
“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. Dr. Aleppo, a principal investigator in Welldoc’s clinical validation study for this product, has conducted extensive research focused on how CGM data can inform dosing in clinical practice.
Welldoc partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs. CGM continues to grow in utilization across broader populations living with type 1 and type 2 diabetes. This enhanced functionality will help the organizations who support these populations provide extended diabetes management services and care.
Ian Cadieux, Head of Regulatory Affairs at Welldoc, said, “A device providing insulin therapy adjustments based on CGM inputs must meet specific requirements to be cleared under the 510(k) program, a higher bar than a calculator using blood glucose meter readings alone. The Welldoc team rose to the occasion, showcasing their capabilities to satisfy these special controls, which include demonstrating clinical validity, cybersecurity, useability and effective risk mitigation.”
For more information regarding Welldoc’s 11th FDA Clearance, go to: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222888
Welldoc®, a digital health leader revolutionizing chronic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with chronic conditions, enabling improved health and outcomes. Welldoc’s comprehensive chronic care platform provides multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, and mental wellbeing. Welldoc’s flagship product, BlueStar®, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. Welldoc partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs. Welldoc continues to be recognized for our leadership, innovation and partnership across the healthcare industry. This year, Welldoc was named the “Best Overall Digital Health Company” by MedTech Breakthrough, and also received the Innovation and AI Excellence Awards from Business Intelligence Group. In addition to achieving 11 510(k) clearances for its digital health platform designed to support diabetes health, Welldoc has also built an IP portfolio of 40 patents for its advanced AI and first-in-class tech and currently has more than 70 clinical publications. Among Welldoc’s extensive library of clinical research, Welldoc has 17 publications focused on understanding the value of combining CGM with artificial intelligence (AI) powered digital health solutions. For more information, visit www.welldoc.com. For more information, visit www.welldoc.com. Follow us on LinkedIn and Twitter.
Megan Prock McGrath