Medtronic nabs CE marks for Guardian 4 sensor, expanded use for smart insulin pen

Medtronic on Wednesday said it received the CE mark for its Guardian 4 glucose sensor, which requires no fingersticks for calibration or diabetes treatment decisions. The EU nod allows the next-generation sensor to be used as a stand-alone continuous glucose monitoring (CGM) system, or to be integrated with either the MiniMed 780G insulin pump or InPen smart insulin pen. The company announced that it also received a CE mark that expands InPen's functionality to include multiple daily injections (MDI).

Sean Salmon, president of Medtronic's diabetes business, said "we're pleased to enhance the customer experience through these advancements and look forward to delivering a strong cadence of innovations to eliminate the burden of constant decision making that people with diabetes carry on a daily basis." The new offerings are scheduled to be launched in the EU later this fall.

The InPen, which Medtronic gained through its takeover of Companion Medical last year, is the only smart insulin pen approved in Europe that is integrated with real-time CGM via a smartphone app, according to the company. "The smart MDI system automatically records insulin doses, tracks active insulin, and recommends mealtime and correction doses based on an auto-populated bolus calculator," Medtronic said.

It added that combining InPen with the Guardian 4 CGM system provides real-time glucose readings and alerts alongside insulin dose information, "giving users everything they need to manage their diabetes in one place." Meanwhile, for those who prefer automated insulin delivery via an insulin pump, Medtronic said that by integrating Guardian 4 with the MiniMed 780G system, insulin delivery is automatically adjusted and corrected every five minutes with no need for fingersticks.

In the US, the InPen received FDA 510(k) clearance in 2016, while the Guardian 4 sensor and MiniMed 780G system are for investigational use only.

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