Medtronic scores European approvals for 2 diabetes management devices

Medtronic headquarters
The newly cleared Guardian 4 sensor can be either used as a standalone continuous glucose monitor or integrated into Medtronic’s insulin pumps and pens to add real-time glucose monitoring alongside insulin tracking. (Medtronic)

For the last few years, Medtronic has been on a mission to make diabetes management as hassle-free as possible, aided by a slew of buyouts, product launches and integrations and regulatory OKs.

The latest push toward this goal arrives via two new European approvals for Medtronic’s suite of diabetes monitoring and management devices.

The first of these CE marks allows for expanded functionality of the InPen, a connected insulin pen designed for users requiring multiple daily injections.

The “smart” Bluetooth-enabled pen, which has previously been cleared in both Europe and the U.S., is the first of its kind to integrate with continuous glucose monitoring technology, allowing users to simultaneously track glucose readings and insulin dose information through the same connected app.

Medtronic began rolling out the InPen last November, following its August acquisition of the device’s original maker, Companion Medical. At the time, Medtronic said it would transition the device’s glucose and insulin tracking from Companion’s legacy app to one designed by Medtronic.

The medtech giant also outlined plans to soon make the InPen compatible with longer-acting insulins. The device, which has a lifespan of about a year, currently dispenses only short-acting insulins, though the connected smartphone app can issue alerts to remind users to take long-acting insulin and lets them manually track those doses in the app.

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Medtronic’s other recent CE mark was bestowed upon the Guardian 4 sensor. The sensor can be used either as a standalone continuous glucose monitor or in tandem with the InPen or Medtronic’s MiniMed 780G insulin pump.

When integrated into the InPen platform, the Guardian 4 will upload real-time glucose readings and alerts to the smart pen’s app. Alternatively, if the sensor is used with the MiniMed system, the insulin pump will use the sensor’s readings to automatically adjust insulin delivery every five minutes.

With these clearances under its belt, Medtronic will begin rolling out the upgraded InPen and the Guardian 4 sensor in Europe later this fall.

“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,” said Sean Salmon, president of Medtronic’s diabetes business.

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The dual clearances arrived amid Medtronic’s reports of 37% year-over-year growth in total revenue for the fourth quarter of fiscal year 2021, which ended April 30. For the entire fiscal year 2021, the company reported about $30.1 billion in global revenue, up just 4% from 2020.

Nearly $8.2 billion of that came in the fourth quarter, thanks in large part to the revival of elective procedures that came to a screeching halt during the same period last year. CEO Geoff Martha noted in a release that, by the end of the fiscal year, most of Medtronic’s markets had returned to “near normal, pre-COVID growth rates.”

That included the diabetes business, which saw only about 2% growth for the entire year, but an impressive 14% jump in the fourth quarter. During that period, global revenue totaled $647 million, driven by increased sales of CGM devices and the MiniMed insulin pump systems.