Medtronic’s InPen app gets FDA clearance
By HME News Staff
Updated 12:00 PM CST, Thu November 21, 2024
GALWAY, Ireland - Medtronic has received clearance from the U.S. Food and Drug Administration 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. 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, the company says. "I'm thrilled about the launch of the Medtronic Smart MDI system with the InPen app and Simplera CGM,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. "This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management. By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia." 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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