i-SENS, a Kosdaq-listed biotech company, said it received product approval for CareSens Air, its continuous glucose monitoring (CGM) device, from the European Conformité Européenne (CE) Medical Device Regulation (MDR) last Thursday.

i-SENS' CGM device, CareSens Air, became the first locally developed CGM to receive approval from the European Conformité Européenne (CE) Medical Device Regulation (MDR).
i-SENS' CGM device, CareSens Air, became the first locally developed CGM to receive approval from the European Conformité Européenne (CE) Medical Device Regulation (MDR).

The CareSens Air CGM system offers a non-invasive solution for diabetes management, allowing users to monitor their glucose levels in real-time without the need for finger-prick blood samples.

The device, which can be worn continuously for up to 15 days, transmits glucose readings to a smartphone app every five minutes, enabling users to track their glucose levels conveniently and manage their condition more effectively.

According to the company, the approval from the CE MDR, a mandatory regulatory requirement for medical devices intended for the European market, opens the door for the company to distribute its CGM system across the European Union and other countries that recognize CE certification.

The company has been actively producing and selling CareSens Air in Korea since last year and plans to launch the product in Europe and other international markets soon.

The company is also working on obtaining reimbursement to ensure that diabetic patients can receive insurance benefits when purchasing the product.

"We are pleased to be the first domestic CGM to receive a product license in Europe," i-SENS CEO Nam Hak-hyun said. "Through this product license, we will proceed with CareSens Air's overseas expansion in Europe and other countries in earnest.

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