Welldoc Lands 11th FDA Clearance with BlueStar

In a remarkable display of innovation and dedication to improving chronic care, Welldoc, a prominent digital health leader, has secured its 11th FDA 510(k) clearance for BlueStar®, its award-winning digital health solution for diabetes management. This milestone follows closely on the heels of the company's 10th 510(k) clearance, solidifying its position as a frontrunner in revolutionizing chronic care.

The latest clearance is a game-changer for individuals with complex insulin regimens. BlueStar's new functionality allows it to connect directly to Continuous Glucose Monitoring (CGM) data, using real-time glucose levels and trend arrows to provide precise and in-the-moment insulin dosage guidance. Notably, Welldoc became the first company to receive clearance for a CGM-informed bolus calculator designed for adults who require multiple daily insulin injections.

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This achievement is a testament to Welldoc's commitment to transforming chronic care. Kevin McRaith, President and CEO of Welldoc, highlights the company's ongoing efforts to develop digital health capabilities that leverage CGM data to create highly personalized solutions for individuals with complex health needs.

The scope of Welldoc's chronic care platform extends beyond diabetes, encompassing pre-diabetes, hypertension, heart failure, weight management, obesity, and mental health. BlueStar, the flagship product, empowers individuals with diabetes to take control of their health, fostering improved communication with their healthcare providers.

Dr. Grazia Aleppo, an endocrinologist from Northwestern University Feinberg School of Medicine and a key investigator in Welldoc's clinical validation study, underscores the significance of BlueStar's CGM-informed capabilities. By tapping into CGM data, the solution assists individuals in achieving their glucose targets by providing precise insulin dosing guidance based on real-time information.

The rising adoption of CGM among both type 1 and type 2 diabetics underscores the importance of Welldoc's achievement. This enhanced capability will enable organizations supporting these individuals to deliver more comprehensive and effective diabetes control services and care.

Furthermore, Ian Cadieux, Head of Regulatory Affairs at Welldoc, emphasizes the rigorous standards that must be met for a device providing insulin therapy adjustments based on CGM inputs to receive FDA clearance. The Welldoc team successfully demonstrated clinical validity, cybersecurity measures, usability, and risk mitigation, surpassing these stringent requirements.

Welldoc's dedication to improving health outcomes and reducing costs has made it a valuable partner for health plans, healthcare systems, and employers. The company's innovative approach to integrating real-time, actionable information into the daily lives of chronic disease patients has garnered recognition and accolades in the healthcare sector.

In 2023, Welldoc was honored with the title of "Best Overall Digital Health Company" by MedTech Breakthrough, and it received the Innovation and AI Excellence award from the Business Intelligence Group. With over 70 clinical papers, 40 patents for its cutting-edge AI technology, and a robust clinical research library, Welldoc is at the forefront of digital health innovation.