Senseonics implantable blood glucose monitor is CE certified

Senseonics implantable blood glucose monitor is CE certified

OFweek Medical Network has never lacked innovation in the field of medical devices, and companies that cannot innovate will eventually be abandoned by this industry. Recently, the innovation of the medical device company Senseonics has paid off. The company's subcutaneous implantable blood glucose monitoring system, Eversense Continuous Glucose Monitoring (CGM), has received CE certification from the European Union.

Dr. Tim Goodnow, president and CEO of the company, said that this is an important victory for the company, and the Eversense CGM system will soon be able to enter European markets and serve diabetic patients. However, the company did not mention the timetable for the launch of the product after CE certification. But Dr. Tim Goodnow said the product will be first marketed in Sweden. Since CE certification is only the threshold for entering the EU member countries' market, Sensonics needs to negotiate separately with each member state to finally promote the CGM system to the European market.

In addition, the company plans to submit relevant application materials to the US FDA by the end of this year. The company expects that the FDA will decide whether to allow the Eversense CGM system to log into the US market in the second half of next year.

The Eversense CGM system is a device that monitors a patient's blood glucose level by implanting the upper arm of a diabetic patient. The device is valid for up to 90 days. Eversense CGM uses a fluorescent polymer that is sensitive to blood glucose levels. When the blood glucose concentration changes, the signal of the biocompatible material changes, and this signal change is transmitted to the device worn by the patient in real time. When the patient's blood sugar is too low or too high, the supporting mobile device will immediately alarm. If the device is no longer around, the detector device itself will vibrate alarm to warn the patient of possible risks. Goodnow said that the company hopes that this device will help diabetic patients to maintain blood sugar stability and ensure their health and safety.

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