Medical technology company Medtronic has secured CE mark approval for its InPen smart insulin pen for multiple daily injections (MDI).
The company has also received CE mark approval for its Guardian 4 sensor, which is free from fingersticks for calibration or diabetes treatment decisions.
The approval enables to incorporate the next-generation sensor with either the MiniMed780G insulin pump system or InPen, as well as for stand-alone continuous glucose monitoring (CGM) use.
Medtronic is planning to commercially launch the latest innovations in European markets by the end of the second quarter this year.
The InPen is claimed to be the first and only smart insulin pen secured approval in Europe, which is integrated with real-time CGM through one convenient smartphone app.
The smart MDI system holds the potential to automatically record insulin doses, track active insulin and suggest mealtime, as well as offer correct doses based on an auto-populated bolus calculator.
By incorporating InPen with the Guardian 4 CGM system, the device will offer real-time glucose readings and alerts alongside insulin dose information to better manage their diabetes.
According to Medtronic, the MiniMed 780G system with Guardian 4 sensor automatically adjusts and corrects insulin delivery every five minutes with no fingersticks for individuals who prefer automated insulin delivery through an insulin pump.
Medtronic diabetes business president and executive vice 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 prioritize what matters most to our customers — a technology experience that’s easy but doesn’t compromise the outcomes they deliver.”
Guardian 4 sensor and the MiniMed 780G system are available for investigational use only in the US.
Earlier this month, Medtronic secured CE mark approval for its Evolut PRO+ TAVI system to treat symptomatic severe aortic stenosis patients in Europe.
