Marks 8th FDA clearance for BlueStar, the only reimbursable software as a medical device for diabetes that integrates with all of a patient's existing devices
Welldoc, revolutionizing digital health with the first FDA-cleared Software as a Medical Device (SaMD) for diabetes, announced today 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 health care 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 his or her patient, and BlueStar does the rest,” said Dr. Mansur Shomali, 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 that works with a patient’s existing devices. Patients can seamlessly integrate BlueStar with blood glucose monitors, blood pressure cuffs, or fitness trackers, improving convenience and reducing out of pocket costs. BlueStar, backed by more than 45 peer-reviewed clinical posters and publications, also:
- 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.
Source: Company Press Release