News & Updates

Welldoc Submits 510(k) Filing to U.S. Food and Drug Administration to Expand its BlueStar® Digital Therapeutic to Help More Individuals Living with Diabetes

February 6, 2019

Welldoc’s chronic disease portfolio grows with new features to support people with both type 1 and type 2 diabetes

Columbia, MD – February 6, 2019Welldoc®, a leading digital health company, announced today its filing at the end of 2018 with the U.S. Food and Drug Administration (FDA) for 510(k) clearance of additional features of its BlueStar® digital therapeutic. The new enhancements include Continuous Glucose Monitoring (CGM) integration, as well as features to support individuals living with type 1 diabetes. This filing demonstrates Welldoc’s commitment to providing BlueStar as a digital therapeutic to support more people living with diabetes.

“Welldoc remains focused on a patient-first approach in our BlueStar innovations and continues to expand to support all individuals with diabetes,” said Welldoc Medical Director Mansur Shomali, MD, CM. “People with type 1 diabetes often struggle with many challenges in their daily schedules—notably insulin-dosing hurdles. Our goal is to bring these individuals support, through this new version of BlueStar. We’ll also take the dense and often complex glucose data provided from CGM and transform it into actionable information.”

BlueStar’s insulin-dosing support has been further enhanced with the addition of an insulin on board (IOB) feature, which helps minimize the risk of hypoglycemia. In addition, BlueStar users will be able to connect to their CGM and receive daily insights that integrate medication, food and activity coaching with their glucose data. Healthcare providers will also be able to receive their patient’s CGM data, along with self-management data, in BlueStar’s comprehensive SMART Visit Report.

Last month, Welldoc announced its digital therapeutic BlueStar® has secured its 10th patent. This is a significant digital health milestone, supporting Welldoc’s commitment and innovation in digital health to create a simple, sustainable and scalable solution to improve population health for individuals living with diabetes.

About Welldoc®

Welldoc® is a leading digital therapeutic company revolutionizing chronic disease management to help transform lives. The Company’s groundbreaking technology helps guide individuals through the complicated journey of living with chronic diseases, with a goal of helping them self-manage their conditions, while connecting them to their own healthcare team. By utilizing Welldoc’s digital therapeutic solutions, payers, employers and healthcare systems can streamline their resources by focusing on a digital health solution to help better manage their populations living with multiple and costly chronic diseases. Welldoc is based on a life science business model—having conducted multiple randomized clinical trials resulting in more than 40 peer-reviewed publications. IBM Watson Health™ conducted an innovative economic analysis for Welldoc using the MarketScan® Commercial Claims and Encounters Database and the MarketScan® Medicare Supplemental and Coordination of Benefits Database demonstrating an opportunity to save a range of $254 to $271 per user per month with the use of the flagship BlueStar® digital therapeutic. Welldoc has a solid foundation in the development of solutions for the management of diabetes and is rapidly creating other chronic disease solutions. This year, Welldoc secured a patent for the Software Engine Technology that powers BlueStar. Notably, this is the Company’s tenth issued patent.  For more information, visit www.welldoc.com.