Welldoc Submits 510(k) for Bolus and Premixed Insulin Titration Program as Part of BlueStar®

Filing marks ninth 510(k) for digital diabetes solution BlueStar

Columbia, MD – December 14, 2020 – Welldoc®, a trailblazer in digital health that is revolutionizing chronic disease management to help transform lives, today announced the filing of its ninth 510(k) with the U.S. Food and Drug Administration (FDA) for BlueStar, an FDA-cleared digital health solution for diabetes. With the filing, BlueStar looks to add bolus and premixed insulin titration for type 2 diabetes to its comprehensive diabetes platform. In June, Welldoc announced FDA clearance for the BlueStar Insulin Adjustment Program for basal insulin titration. This current submission would expand insulin dosing support to include most types of insulin. The 510(k) was submitted on Nov 23, 2020.

“Dosing insulin is challenging for both patients and clinicians,” said Welldoc Chief Medical Officer Mansur Shomali, MD, CM. “By going digital, our new bolus and premixed insulin titration program goes beyond the pencil and paper processes we traditionally have relied upon to make the process of adjusting insulin easier and safer.”

BlueStar is an FDA-cleared digital health solution for diabetes, backed by more than 52 peer-reviewed clinical posters and publications, that:

  • Engages people with Type 1 and Type 2 diabetes;
  • Delivers tailored, real-time feedback – 24/7, on or offline – to improve long-term health;
  • Connects users with their own care team to provide new opportunities to optimize care;
  • Seamlessly integrates with blood glucose meters, pharmacies, labs, activity and fitness trackers;
  • Aggregates critical data to assist by delivering actionable insights to the user’s care team;
  • Allows providers to use remote patient monitoring codes for reimbursement.

About Welldoc

Welldoc® is revolutionizing chronic disease management to help transform lives. BlueStar®, a FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their conditions and enhancing connections to their healthcare team. Welldoc streamlines the relationships between payers, employers and healthcare systems resources, with the goal of improving population health and reducing the costs of chronic diseases. For more information, visit www.welldoc.com.


Subscribe for Updates

Media Inquiries

For media inquiries, please email media@welldocinc.com


Taking Diabetes Self-Management to the Next Level