Dive Brief:

Medtronic received Food and Drug Administration clearance for its new InPen smart insulin pen app that can recommend corrections for missed or inaccurate insulin doses at mealtime.

The authorization paves the way for the launch of Medtronic’s Smart MDI system, which combines InPen with the Simplera continuous glucose monitor (CGM), the company said Wednesday.

With the clearance, Medtronic said Smart MDI will be the first system on the market to provide personalized insights on when and how much insulin to dose in real-time for people who take multiple daily injections.

Dive Insight:

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.

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

On an earnings call this week, CEO Geoff Martha said the Simplera Sync sensor, designed to work with the company’s automated insulin delivery algorithm, is gaining strong acceptance in international markets.

Simplera Sync is under FDA review separately.