Medtronic receives CE mark for two aspects of diabetes products

Medtronic has received the CE mark for expanded functionality of the company's InPen smart insulin pen for multiple daily injections (MDI). The company has also received CE Mark for its Guardian 4 sensor, which requires no fingersticks for calibration or diabetes treatment decisions. 

The CE mark allows this sensor to be integrated with either the MiniMed 780G insulin pump system or InPen, or for stand-alone continuous glucose monitoring (CGM) use. These latest innovations will begin commercial launches in European markets later this Fall (Q2 FY22).

Prof. Goran Petrovski, diabetologist – Endocrinology Unit, Sidra Medicine, Doha, Qatar, said: "We look forward to having multiple ways to help our patients manage their diabetes as we know that patient needs and preferences can vary greatly. Living with diabetes is challenging, and these innovations are finding new ways to reduce the work that people must do every day to stay healthy."

The InPen is integrated with real-time CGM via a smartphone app. The smart MDI system automatically records insulin doses, tracks active insulin, and recommends mealtime and correction doses based on an auto-populated bolus calculator. By combining InPen with the Guardian 4 CGM system, it will provide real-time glucose readings and alerts alongside insulin dose information giving users everything they need to manage their diabetes in one place. Rather than switching between apps, users will have the ability to see all their information in real-time, in one view. Combined insulin dose and glucose reports can be shared with care partners and healthcare professionals as well.

For individuals who prefer automated insulin delivery via an insulin pump, the MiniMed 780G system with Guardian 4 sensor will automatically adjust and correct insulin delivery every five minutes with no fingersticks. By pairing the MiniMed 780G system with the Medtronic Extended infusion set that is indicated for up to seven days, twice as long as current infusion sets, insulin pump users may need to perform 70 fewer set changes per year. 

Sean Salmon, executive vice president and president of the diabetes business at Medtronic, 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. 

“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."