Welldoc receives additional FDA approval for digital health solution

June 9, 2020

Welldoc announced that the U.S. Food and Drug Administration (FDA) has cleared an additional feature for the digital health product BlueStar Rx, which supports individuals using long-acting insulin. The Insulin Adjustment Program (IAP) supports the process of basal insulin titration by healthcare providers for adults with type 2 diabetes. Patients who are prescribed IAP as part of BlueStar, will benefit from the ease of real-time adjustments to their insulin.

“With BlueStar’s Insulin Adjustment Program, a provider prescribes a safe starting dose of insulin for the patient, and BlueStar does the rest,” said Mansur Shomali, MD, Welldoc’s Chief Medical Officer. “The patient no longer has to wait to talk to his or her provider to adjust the insulin. The next time the patient meets with his or her health care provider, the insulin dose has been optimized and they can spend their visit focusing on other important elements of the patient’s care.”

BlueStar is the only FDA-cleared and reimbursable software as a medical device (SaMD) that works with a patient’s existing devices, according to Welldoc. Patients can seamlessly integrate BlueStar with blood glucose monitors, blood pressure cuffs, or fitness trackers, improving convenience and reducing out of pocket costs.

BlueStar also aggregates data to help deliver actionable insights to the user’s care team. It also allows providers to use remote patient-monitoring codes for reimbursement.

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