Two CE Marks for Medtronic kit

As reported by Zacks Equity Research in June 2021, Medtronic recently secured two back-to-back European regulatory approvals in the diabetes management space, the first for its InPen smart insulin pen, the second for Guardian 4 sensor. Both received a CE Mark. The commercial launch of both will begin sometime later this year.

InPen got expanded approval for multiple daily injections (MDI). Smart MDI system automatically records insulin doses, tracks active insulin and recommends mealtime and correction doses based on an auto-populated bolus calculator.

InPen is the first smart insulin pen approved in Europe, which can work together with real-time CGM (continuous glucose monitoring) via one convenient smartphone app. Inpen got integrated to Medtronic’s product line following the company’s acquisition of connected insulin pen company, Companion Medical in September 2020.

The latest CE Mark approval for the Guardian 4 sensor 3 enables it to be integrated with the MiniMed 780G insulin pump system or InPen or stand-alone CGM use. Notably, the Guardian 4 sensor 3 does not require any fingersticks for calibration or diabetes treatment decisions.

InPen combined together with the Guardian 4 CGM system is claimed to provide real-time glucose readings and insulin dose information to the user in one place. Rather than using multiple applications with this integration, users will be able to see all their information real-time in one single app. This will help them with smarter dosing decisions to manage their sugar levels in one view rather than taking the help of different apps.

The MiniMed 780G system with Guardian 4 sensor will automatically adjust and correct insulin delivery every five minutes with no fingersticks. These two latest innovations will enable Medtronic to offer the only pump that adjusts and corrects every five minutes with an infusion set that lasts twice as long. These will improve the user experience of insulin pump therapy.


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