[Edaily Reporter Kwon Oh Seok ] i-SENS, Inc.(099190)has begun the European certification process for its next-generation continuous glucose monitor (CGM), the “CareSense Air 2,” and is now fully launching its push into the global market.

i-SENS, Inc. announced on the 13th that it has applied for new European CE certification for the “CareSense Air 2.” At the same time, the company also applied for a CE amendment certification to expand the age range for pediatric and adolescent use of its existing CGM product, “CareSense Air,” and to add predictive alert features.
CareSense Air 2 is a next-generation product that offers improved performance and user convenience compared to its predecessor. The sensor wear time has been extended from 15 days to 18 days, and the initial stabilization time has been reduced from 30 minutes to 20 minutes. The sensor’s size has been reduced by approximately 70%, enhancing wearability.
The company is also working to enhance the features of the existing product. i-SENS, Inc. is pursuing the expansion of the CareSense Air’s age range to include children and adolescents, along with the addition of a “Predictive Alert” feature. Predictive Alerts are designed to provide advance notice when blood glucose levels are likely to fall outside the target range, supporting proactive responses to hypoglycemia and hyperglycemia.
The company explains that this is particularly significant for expanding its customer base, as early experiences with the product among pediatric and adolescent patients are likely to lead to long-term use.
Europe, along with North America, is considered a key region in the global CGM market. i-SENS, Inc. currently supplies CGM products to 29 countries, including 13 in Europe. The company has also secured insurance coverage in eight countries, including the United Kingdom, Germany, Belgium, Poland, the Czech Republic, Hungary, Croatia, and Estonia.
i-SENS, Inc. plans to use this certification application as an opportunity to strengthen its product competitiveness and expand its presence in the European market.
A company official stated, “We will enhance our competitiveness in the global market by improving user convenience in areas such as wear time, initial stabilization time, and sensor size,” adding, “We will expand into overseas markets, including Europe, by upgrading our product lineup and securing global certifications.”