Medtronic Says FDA Clearance For New InPen App

(RTTNews) - Healthcare technology firm Medtronic plc (MDT) announced Wednesday the U.S. Food and Drug Administration (FDA) clearance for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera continuous glucose monitor (CGM).

The company's Smart MDI system combines its InPen smart insulin pen with its newest Simplera CGM, the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.

With this clearance, the new Smart MDI system will be the first system in the market to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses. It will recommend corrections for missed or inaccurate insulin doses for individuals on multiple daily injection (MDI) therapy.

The Missed Dose alert function helps to minimize the frequency of these glucose highs. The Medtronic Smart MDI system reduces the guesswork out of diabetes management, helping to address a significant unmet need for MDI users who struggle with juggling numerous decisions related to insulin dosing on a daily basis.

Medtronic will initiate a limited market release beginning with existing standalone CGM and InPen customers followed by a broad commercial launch.