Medtronic has earned U.S. Food and Drug Administration (FDA) clearance for its new InPen app, which features missed meal dose detection.

This paves the way for launch of the company’s Smart MDI system with the Simplera continuous glucose monitor (CGM). Medtronic’s Smart MDI system merges its InPen smart insulin pen with its newest Simplera CGM. Simplera is the company’s first disposable, all-in-one CGM and is half the size of its previous CGMs.

The Simplera CGM received FDA approval in August 2024.

Medtronic said this clearance makes its system the first in the market to recommend corrections for missed or inaccurate insulin doses. This offers real-time, personalized insights for people on multiple daily injection (MDI) therapy.

The company said its Smart MDI system minimizes the guesswork involved in diabetes management. It helps address a significant unmet need for MDI users who juggle various decisions related to insulin dosing on a daily basis.

Medtronic said it will begin a limited market launch starting with existing standalone CGM and InPen customers, followed by broader commercial rollout.

“I’m thrilled about the launch of the Medtronic Smart MDI system with the InPen app and Simplera CGM. This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. “By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia.”