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Medtronic announces FDA clearance for its new InPen app
The Fly

Medtronic announces FDA clearance for its new InPen app

Medtronic (MDT) announced FDA clearance for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera continuous glucose monitor, or CGM. The company’s Smart MDI system combines its InPen smart insulin pen with its newest Simplera(TM) CGM – the company’s first disposable, all-in-one CGM that’s half the size of previous Medtronic CGMs. With this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection therapy. Medtronic will initiate a limited market release beginning with existing standalone CGM and InPen customers followed by a broad commercial launch.

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