Welldoc Seeks 510(k) Clearance to Expand Diabetes Platform

Maryland-based Welldoc has filed an additional 510(k) application with the FDA for its BlueStar digital health diabetes platform, requesting clearance to add bolus and premixed insulin titration for type 2 diabetes.

The BlueStar app provides feedback for type 1 and 2 diabetes patients online or offline and integrates with blood glucose meters, trackers, smart watches and other devices.

“Dosing insulin is challenging for both patients and clinicians. By going digital, our new bolus and premixed insulin titration program goes beyond the pencil and paper processes we traditionally have relied upon to make the process of adjusting insulin easier and safer,” said Welldoc’s Chief Medical Officer Mansur Shomali.