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May 27, 2021updated 01 Nov 2021 8:49am

Medtronic obtains CE mark for Guardian 4 Sensor and smart insulin pen

Medtronic obtains CE mark for its InPen smart insulin pen and Guardian 4 sensor for better diabetes management.

Medtronic has obtained CE mark for prolonged use of its InPen smart insulin pen for multiple daily injections (MDI) and its Guardian 4 sensor for better diabetes management.

The latest approval permits the Guardian 4 sensor, which does not need fingersticks for calibration or diabetes treatment decisions, to be used with either the InPen, the MiniMed 780G insulin pump system or as a separate continuous glucose monitoring (CGM) device.

The company noted that the InPen, which is linked to real-time CGM through a smartphone app, is the first-ever smart insulin pen to get approval in Europe.

The smart MDI system can record insulin doses, check active insulin and suggest mealtime and correction doses using an auto-populated bolus calculator.

Connecting InPen with the Guardian 4 CGM system is meant to offer real-time glucose levels and notifications together with insulin dose data. This will help users better manage their diabetes.

In addition, the insulin dose and glucose reports can be sent to care partners and healthcare specialists.

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For users who prefer automated insulin delivery through a pump, the MiniMed 780G system will regulate and correct insulin delivery automatically every five minutes, without a need for fingersticks, when combined with the Guardian 4 sensor.

The MiniMed 780G system can be integrated with Medtronic’s extended infusion set, which can be used for up to seven days.

Combining these two devices could enhance customers’ experiences of insulin pump therapy use.

Medtronic Diabetes business executive vice-president and president Sean Salmon said: “We know that diabetes is a very personal journey, and we want to meet people where they are with solutions that fit their lifestyle and needs while enabling them to experience seamless support through all their life transitions.

“That’s why we’ve made the commitment to expand our portfolio and prioritise what matters most to our customers – a technology experience that’s easy but doesn’t compromise the outcomes they deliver.”

Medtronic intends to launch Guardian 4 sensor and InPen smart insulin pen commercially in Europe in the second quarter of the fiscal year 2022.

Currently, Guardian 4 sensor and the MiniMed 780G system are available in the US for investigational purposes only.

Earlier this month, Medtronic launched its SonarMed airway monitoring system, which checks for endotracheal tube (ETT) obstruction, in the US market.

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