This is Welldoc’s 8th 510(k) filing to the U.S. Food and Drug Administration
Columbia, MD – January 16, 2020 – Welldoc, a leading digital health company, announced today the filing of a 510(k) with the U.S. Food and Drug Administration (FDA) for an additional feature of its BlueStar® digital health product. The proposed addition, which requires a prescription from a health care provider, is an Insulin Adjustment Program feature that is designed to support the process of basal insulin titration by health care providers for adults with type 2 diabetes.
“Determining the optimal dose of long-acting insulin is often complicated. Health care providers usually initiate basal insulin for their patients at a low dose to avoid hypoglycemia, and then adjust the dose over time using fasting blood glucose data,” said Welldoc Chief Medical Officer Mansur Shomali, MD, CM.
BlueStar, the FDA-cleared digital health app engages people with type 1 and 2 diabetes and delivers precise, real-time feedback to help improve long-term health. With seamless integration to blood glucose meters, pharmacies, labs, activity and fitness trackers, BlueStar makes managing a user’s everyday life as simple as possible. On the backend, BlueStar aggregates various dimensions of data and delivers actionable insights for the user’s care team, providing new opportunities to optimize care.
Welldoc®, a founding member of the Digital Therapeutics Alliance, is a pioneer in revolutionizing chronic disease management to help transform lives. BlueStar® was the first FDA-cleared digital health solution that guides individuals through the complicated journey of living with diabetes. By helping individuals with chronic disease self-manage their conditions and connecting them to their own healthcare team, Welldoc streamlines payers, employers and healthcare systems resources by focusing on a digital health solution to help better manage their populations living with multiple and costly chronic diseases. Having conducted several randomized clinical trials, demonstration projects, and real-world studies resulting in 45 peer-reviewed publications, Welldoc is based on a life science model. BlueStar has been recognized by IQVIA in 2017 as the “Top App” for type 2 diabetes treatment, awarded Diabetes Technology Society’s 2019 Digital Diabetes Congress Mobile App Contest in the “Established App” category, and MedTech Breakthrough’s 2019 “Best Personal Health App” award. Welldoc has created a suite of products that apply across a chronic disease domain. In 2019, Welldoc received its 10th patent with 9 others pending. For more information, visit www.welldoc.com.