i-SENS Obtains European Certification for 'Domestic CGM'

i-SENS announced on the 29th that its continuous glucose monitor (CGM) CareSens Air has received product approval under the European CE MDR.

i-SENS's continuous glucose monitor (CGM) CareSens Air [Photo by i-SENS]

Unlike traditional self-monitoring blood glucose devices, continuous glucose monitors are medical devices that allow patients to monitor their blood glucose levels in real time simply by attaching a patch to their body without the need for daily blood sampling. CareSens Air, developed by i-SENS, was the first domestically produced CGM to receive approval from the Ministry of Food and Drug Safety in June last year. With the recent CE MDR certification, it has now also obtained approval in Europe.

CE MDR is an international medical device regulation that must be complied with to export products to the European market. Through this certification, i-SENS can now sell continuous glucose monitors in countries including the European Union based on CE certification.

CareSens Air can be used continuously for 15 days. Without a separate dedicated receiver, the sensor transmits blood glucose values to a smartphone application every 5 minutes. Users can check their blood glucose levels in real time on their smartphones for systematic glucose management. The user calibration function enhances reliability in accuracy, and blood glucose data and statistics over the usage period are also provided. It is released in individual packaging, making it easy for users who need short-term use to purchase.

Nam Hak-hyun, CEO of i-SENS, said, “We are pleased that i-SENS products have become the first domestically produced CGM to receive product approval in Europe,” adding, “We will actively pursue overseas expansion of CareSens Air, including in Europe, through this product approval.”