The First Domestic Continuous Glucose Monitor Released... i-SENS Obtains MFDS Product Approval

Following Abbott, Dexcom, and Medtronic, the 4th Domestic Company
Product Mass Production and Launch Scheduled for Q3

i-SENS announced on the 21st that it received product approval from the Ministry of Food and Drug Safety on the 20th for the first domestically produced continuous glucose monitor (CGM), 'CareSens Air.'

i-SENS Continuous Glucose Monitor (CGM) 'CareSens Air'.
Photo by i-SENS

A continuous glucose monitor is a medical device that allows real-time blood glucose monitoring through a sensor attached to the body without the need for finger-prick blood sampling.

This product approval marks the first domestic approval for a continuous glucose monitor. i-SENS completed the submission of documents related to the CGM product approval application in early March. Although the approval was initially expected around September, it was obtained without the need for supplementary documents. Currently, continuous glucose monitors from Abbott (FreeStyle Libre), Dexcom (Dexcom G6), and Medtronic (Guardian 4) have been approved and are sold domestically, but all are products from foreign companies.

The product name of the continuous glucose monitor approved by the Ministry of Food and Drug Safety is 'CareSens Air.' i-SENS explained that CareSens Air is the smallest and lightest among CGMs released in Korea and offers the longest usage period with 15 days of continuous use.

Additionally, without a separate dedicated receiver, the sensor transmits blood glucose values to a smartphone app every 5 minutes and displays blood glucose statistics for the past 24 hours. This allows users to check real-time blood glucose levels on their smartphones and manage their glucose through additional data input. Furthermore, the product is released in individual packaging, enabling users who require short-term monitoring to purchase it without burden.

i-SENS plans to begin full-scale mass production and launch of the continuous glucose monitor product within the third quarter of this year. Alongside this, they will register consumable materials for diabetic patients to enable type 1 diabetes patients to receive medical expense support when purchasing the product.

Nam Hak-hyun, CEO of i-SENS, stated, "Since all continuous glucose monitors currently released domestically are foreign products, the first domestically developed continuous glucose monitor by i-SENS holds great significance." He added, "Leveraging our experience in dominating the domestic market for blood glucose meters (BGM), which were previously led by foreign products, we plan to quickly launch continuous glucose monitors in the market and increase our domestic market share."

The global market size for continuous glucose monitors has been growing annually. According to global market research firm Research and Markets, the global CGM market is expected to grow from $4.6 billion (approximately 5.9 trillion KRW) in 2019 to over $31.1 billion (approximately 39.9 trillion KRW) by 2026. The compound annual growth rate (CAGR) during this period is projected to be 27.3%.

Digital healthcare service providers are also positioning blood glucose management using continuous glucose monitors as a key point of their services. Kakao Healthcare plans to launch a digital healthcare platform featuring blood glucose management functions using CGMs in the fourth quarter of this year. To this end, Kakao Healthcare signed a business agreement with i-SENS earlier this year and is collaborating by leveraging platform and product development capabilities. With i-SENS’s CGM receiving product approval from the Ministry of Food and Drug Safety, cooperation between the two companies is expected to gain further momentum.

Meanwhile, i-SENS submitted an application for CE product approval to the European Medicines Agency in March, aiming to launch the product in the European market in the first half of next year.

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