Welldoc Gets FDA’s 510(k) Clearance for Its Diabetes Platform, BlueStar

September 24, 2021

The FDA has granted Columbia, Md.-based Welldoc a 510(k) clearance for its BlueStar insulin dosing platform for treatment of diabetes.

The new clearance expands the insulin dosing the BlueStar system can offer to most types of insulin, including bolus and premixed insulin titration for type 2 diabetes, the company said.

The new dosing capability will “help clinicians optimize insulin management and reduce the burden of care coordination,” Welldoc said.

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