Medtronic announced that it has gained approval in the European Union for a new, disposable, fully-calibrated continuous glucose monitor (CGM). The device, Envision Pro, will be utilized by health care providers in the EU for patients with type 1 diabetes and type 2 diabetes.
Medtronic says that the Envision Pro will produce up to five diagnostic reports to provide information on trends in blood sugar levels in patients. Health care providers can then make therapy recommendations based on the data.
This is the first fully-calibrated Medtronic CGM to enter the market. Medtronic is conducting trials of a fully-calibrated sensor for use with its Guardian Connect CGM. In recent years, Abbott and Dexcom have have released their own popular models of CGMS that do not require fingerstick calibration.
In a press release, Medtronic says it will plan to roll out the CGM in the EU and the Middle East this fall. The Enlite Pro has not been approved in the United States by the FDA, and Medtronic currently has no plans to release the CGM in the U.S.
“Envision Pro will not be launched in the U.S.,” said Pamela Reese, Medtronic’s director of Global Communications, in an email. “However, Medtronic’s goal is to bring future CGM solutions to the U.S. that will build upon the innovations achieved in the Envision Pro CGM system. No specific timeline to share yet. These future U.S. sensors do not have names yet.”
Medtronic does have another CGM for professional use on the market in the United States – the iPro2.
Correction: 9/20/2019 – The Envision Pro sensor is not factory-calibrated, as originally stated in this article, but it is fully calibrated. According to Medtronic, an algorithm leverages multiple sensor signals and applies an advanced proprietary machine learning intelligence to optimize the sensor accuracy.
To read the complete press release on the release of the Envision Pro CGM, click here.
h/t to Close Concerns newsletter for sharing this news in its newsletter from its #EASD2019 coverage.