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Home » FDA clears Welldoc diabetes software

FDA clears Welldoc diabetes software

June 3, 2020 By Sean Whooley

Welldoc announced today that it received FDA clearance for an additional feature of its BlueStar Rx software for users of long-acting insulin.

Patients with diabetes who are prescribed the insulin adjustment program (IAP) as part of BlueStar can now receive real-time adjustments to their insulin with the newly cleared feature, according to a news release.

Columbia, Md.-based Welldoc touts BlueStar as the only FDA-cleared and reimbursable software as a medical device that works with a patient’s existing devices. It can be integrated with blood glucose monitors, blood pressure cuffs or fitness trackers to deliver 24/7 real-time feedback.

“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,” Welldoc chief medical officer Dr. Mansur Shomali said in the release. “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.”

Filed Under: Diabetes, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: FDA, Welldoc

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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