It marks another boost for Medtronic’s CGM portfolio, which will also include an integrated CGM offering through a collaboration with Abbott announced today.
Simplera, the company’s first disposable, all-in-one CGM, comes in at half the size of previous Medtronic CGMs. Its discreet design simplifies the insertion and wear process and eliminates the need for overtape.
Medtronic named its next-generation “Simplera” CGM as a nod to its simplicity. It features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Company officials last fall explained the benefits of the brand new form factor for the medtech giant’s CGM platform.
The Medtronic Simplera platform includes the Simplera CGM for use with the InPen smart insulin pen and Simplera Sync for integration with the MiniMed 780G automated insulin delivery system. The company won CE mark for Simplera with InPen last September. It then picked up CE mark for Simplera Sync with MiniMed 780G this year. Both launched earlier this year, with Medtronic reporting positive feedback around ease of use and insertion.
Medtronic said FDA approval “lays the groundwork” for a future submission for the updated InPen app. This would facilitate integration with Simplera as a smart MDI system. Once the company garners FDA clearance, it plans for a limited market release in the U.S., beginning with existing standalone CGM and InPen customers. Simplera Sync remains investigational and under FDA review in a separate regulatory filing. The company has additional global regulatory submissions pending for Simplera and Simplera Sync.
“Medtronic continues to advance its pipeline for people requiring intensive insulin delivery, including next-generation durable and patch automated insulin delivery systems, smart pens, CGMs, algorithms, software and services and will continue to expand therapy indications,” the company said in a news release.
