i-SENS Applies for European CE Certification for Next-Generation CGM 'CareSens Air 2'

i-SENS has applied for new CE certification in Europe for its next-generation continuous glucose monitoring (CGM) device, 'CareSens Air 2'.

According to i-SENS on July 13, CareSens Air 2 is the company's next-generation CGM product. Compared to the existing model, it extends the sensor wear period from 15 days to 18 days, and reduces the initial stabilization time from 30 minutes to 20 minutes. Additionally, the sensor volume has been reduced by approximately 70%, improving user convenience.

For the existing CareSens Air, i-SENS has also applied for a CE modification certification to expand the user age range to children and adolescents and to add a predictive alert feature. The potential for initial experiences among pediatric and adolescent patients to lead to long-term product use is seen as significant for the company's mid-to-long-term customer base expansion.

The predictive alert function notifies users in advance if their blood glucose is likely to deviate from a certain level, which can help with early response to hypoglycemic or hyperglycemic situations. Since CGM devices enable diabetes patients to continuously monitor blood glucose changes in their daily lives, this feature is highly meaningful in terms of convenience for both patients and caregivers.

Europe is considered one of the most important regions in the global market, alongside North America. i-SENS currently supplies CGM products to 29 countries, including 13 countries in Europe. In eight countries—United Kingdom, Estonia, Hungary, Poland, Czech Republic, Croatia, Germany, and Belgium—the products have also been listed for insurance reimbursement. With this application, i-SENS aims to enhance the competitiveness of its CGM products and further strengthen its presence in the European market.

An i-SENS representative stated, "We will continue to improve user convenience by enhancing factors such as the product's wear period, initial stabilization time, and sensor size, thereby increasing our competitiveness in the global market," adding, "We also plan to expand our presence in the global CGM market, including Europe, by advancing our product lineup and obtaining global certifications."

This content was produced with the assistance of AI translation services.