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


Welldoc Submits 510(k) for Bolus and Premixed Insulin Titration Program as Part of BlueStar®
Welldoc Submits 510(k) for Bolus and Premixed Insulin Titration Program as Part of BlueStar®
Welldoc, a trailblazer in digital health that is revolutionizing chronic condition 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. ....

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