i-SENS said it has received the regulatory approval for CareSens Air, the first locally-developed continuous glucose monitoring (CGM) device, on Tuesday. 

CareSens Air is also the fourth CGM product approved in Korea after those by Medtronic, Abbott, and Dexcom.

A continuous glucose monitor (CGM) is a device that attaches to the body and monitors blood glucose levels in real time. It does not require finger pricking, and can be worn for up to a week.

i-SENS submitted related documents to the government for approval in early March and expected to receive the nod around September.

However, the approval came earlier than expected because the Ministry of Food and Drug Safety did not require any additional supplementary documents.

In March, the company signed a memorandum of understanding with Kakao Healthcare to collaborate on chronic disease management by utilizing their platform and product development capabilities.

Under the accord, Kakao Healthcare will develop digital healthcare solutions and platforms, and i-SENS will continue to develop excellent products for the treatment and healthcare of patients. 

The two companies will also continue to collaborate to improve user convenience and enter the global market.

According to i-SENS, CareSens Air is the smallest and lightest CGM in Korea and has the longest usage period (15 days of continuous use).

The device transmits blood glucose readings from the sensor to the smartphone app every 5 minutes without a separate receiver, and also shows blood glucose statistics for the past 24 hours. It also has a user calibration feature to make the results more reliable.

The company stressed that such features allow users to check their blood glucose readings in real-time on their smartphone and organize their blood glucose management with no additional data entry.

Also, as the product is available in single packages, users who need short-term monitoring can purchase the product with low financial concerns.

Following the approval, i-SENS plans to begin full-scale mass production and launch the CGM in the third quarter of this year.

The company will also immediately proceed with the registration of consumable materials for diabetics so that patients with type 1 diabetes can receive financial support when purchasing the product.

“The first domestic CGM developed by i-SENS is very significant because all the CGMs currently available in Korea are foreign products,” i-SENS CEO Nam Hak-hyun said. “Utilizing the experience of dominating the domestic market for BGMs, we plan to quickly launch our CGM device to the market and increase our domestic market share.”