Welldoc Submits 510(k) to FDA for CGM-Informed Glucose Prediction Feature

Welldoc Builds on its Foundation of 11 Prior FDA 510(k) Clearances with a Generative AI Model Submission

COLUMBIA, Md.--(BUSINESS WIRE)--Welldoc®, a leader in AI-powered cardiometabolic health solutions, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its Continuous Glucose Monitor (CGM)-Informed Glucose Prediction Feature. This submission builds on the company's foundation of 11 FDA 510(k) clearances for type 1 and type 2 diabetes capabilities.

The software feature predicts glucose values up to 2 hours for individuals with type 2 diabetes who do not use insulin. The CGM-informed Glucose Prediction Feature may help increase awareness of future glucose levels, while providing personalized, lifestyle-focused coaching messages designed to empower proactive self-care.

Approximately 80% of the 38 million Americans living with diabetes do not require insulin therapy and manage their condition through diet, exercise, and non-insulin medications.^1,2 This segment is seeing a significant rise in CGM adoption as individuals increasingly seek real-time biological feedback to guide their health journeys.³ However, despite comprising the largest segment of the diabetes population, these individuals often lack the predictive tools necessary to turn that data into proactive self-care.⁴

“For millions of individuals with type 2 diabetes who manage their condition without insulin, the challenge has always been knowing what’s coming next,” said Kevin McRaith, President & CEO of Welldoc. “This capability is designed to shift the user experience from reactive data review to proactive self-care.”

Richard Bergenstal, MD, Executive Director of the International Diabetes Center at HealthPartners Institute Park Nicollet, added, “An important evolution in diabetes management lies in real-time, predictive intelligence. Welldoc is applying CGM trend data to provide a personalized, two-hour glucose prediction window for a broad population. This offers a new opportunity to transform how type 2 diabetes is managed while supporting the potential for optimized engagement and improved clinical outcomes.”

With this submission, Welldoc continues its commitment to advancing digital health innovation for people living with chronic and cardiometabolic conditions.

¹American Diabetes Association. (2024). Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care, 47(1), 26-43.
²Centers for Disease Control and Prevention. (2024). National Diabetes Statistics Report. U.S. Department of Health and Human Services.
³Grand View Research. (2024). Continuous Glucose Monitoring Devices Market Size & Share Analysis Report, 2024-2030. (Refers to the expansion of CGMs into non-insulin and OTC markets).
⁴Klonoff, D. C., et al. (2023). Continuous Glucose Monitor Data Interpretation: The Gap Between Data and Action. Journal of Diabetes Science and Technology.

About Welldoc

Welldoc® is an AI-powered health technology leader committed to connecting people to better, more personalized cardiometabolic care. The company's digital health platform delivers a unified experience for individuals managing diabetes, obesity (including GLP-1 support), hypertension, heart failure, and complex comorbidities including diabetes in pregnancy, sleep apnea, chronic kidney disease (CKD), and metabolic dysfunction-associated steatohepatitis (MASH).

The foundation of Welldoc's solution is healthcare-ready AI, a purpose-built engine grounded in unmatched clinical rigor, with 11 FDA clearances, 60 patents, and more than 100 peer-reviewed publications demonstrating clinical effectiveness and safety. The platform's architecture allows individuals to connect to over 400 devices and data sources, while also integrating seamlessly with electronic health record (EHR) systems, to enable comprehensive data interoperability across care settings.

Welldoc partners across multiple healthcare sectors—including life sciences companies, health plans, health systems, and employers—to drive innovative health programs, improved patient outcomes, and reduced costs at scale. The company has been recognized as a leader in healthcare innovation, named one of TIME and Statista's World's Top HealthTech Companies and awarded "Best Overall Digital Health Company" by MedTech Breakthrough™ for multiple consecutive years. Welldoc is strategically aligned with federal modernization efforts, including being named an early adopter in the CMS 2025 Health Tech Ecosystem Initiative. This ensures the company’s AI-powered solutions support critical programs like the CMS Rural Health Transformation Program (RHTP) focused on rural healthcare access. For more information, visit www.welldoc.com.