Medtronic nets FDA nod for smart insulin pen app

The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.

InPen is a reusable insulin pen that can send dosing information to an app for users. The smart insulin pen also offers dose calculations and tracking for diabetes management.

The InPen app calculates insulin doses based on glucose levels and carbohydrate estimates. The new InPen app can alert users of a missed insulin dosage to help minimize the frequency of glucose highs, Medtronic said.

Simplera is Medtronic’s first disposable CGM and is half the size of the company’s previous CGMs. Medtronic announced FDA approval of the Simplera CGM in August.

The company will combine the InPen with its Simplera CGM into the Smart MDI system.

Sign up for Blog Updates