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Medtronic wins FDA nod for new InPen app to support launch with Simplera CGM

November 20, 2024 By Sean Whooley

Medtronic InPen smart MDI system with Simplera CGM (1)
The InPen with Simplera CGM. [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) announced today that it received FDA clearance for its new InPen insulin delivery system application.

The app features missed meal dose detection and paves the way for the launch of the company’s smart multiple daily injection (MDI) system. That system includes the recently FDA-cleared next-generation Simplera continuous glucose monitor (CGM).

Medtronic’s smart MDI system combines the InPen smart insulin with Simplera, the company’s first disposable, all-in-one CGM that 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.

The medtech giant’s Simplera features a simple, two-step insertion process for people with diabetes using MDI. Company officials last fall explained the benefits of the brand new form factor for the medtech giant’s CGM platform.

Clearance makes the smart MDI system the first on the market to recommend corrections for missed or inaccurate insulin doses, according to a news release. It provides real-time, personalized insights for individuals on MDI therapy. Medtronic says its smart MDI system reduces the guesswork of diabetes management. It helps address an unmet need for MDI users who struggle with juggling numerous decisions around insulin dosing on a daily basis.

Medtronic plans to initiate a limited market release first, followed by a broad launch.

“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, an endocrine clinical pharmacist. “By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia.”

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Technology Tagged With: FDA, Medtronic

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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