South Korean CGM Receives Regulatory Approval

i-SENS, the South Korean maker of CGM said it has won regulatory approval for its CareSens Air.

Image credit: i-SENS

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

In addition, CareSens Air is the fourth CGM product following those from Medtronic, Abbott, and Dexcom to receive approval in Korea.

A continuous glucose monitor (CGM) is an apparatus that is worn on the body and continuously tracks blood glucose levels. It can be worn for up to a week and does not require finger pricking.

Early in March, i-SENS filed the necessary paperwork to the government for approval with the expectation of getting the go-ahead in late September.

The Ministry of Food and Drug Safety did not request any further supporting documentation, thus the approval arrived sooner than anticipated.

The business and Kakao Healthcare inked a memorandum of understanding in March to work together on chronic disease management using their platforms and product development skills.

In accordance with the agreement, i-SENS will continue to create top-notch products for the treatment and healthcare of patients, and Kakao Healthcare will create digital healthcare solutions and platforms.

The two businesses will also keep working together to increase consumer convenience and break into the international market.

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

Without a separate receiver, the device sends blood glucose readings from the sensor to the smartphone app every five minutes. It also displays 24-hour blood glucose trends. In order to increase the accuracy of the results, it also contains a user calibration option.

Related: DexcomG6 CGM Gets Coverage in Alberta for Children and Youth Living With Diabetes

The company emphasized that consumers may organize their blood glucose control using these capabilities and check their blood glucose readings in real-time on their smartphones without having to enter any more data.

Additionally, because the medicine is sold in single packages, consumers who require short-term monitoring can buy it with no financial worry.

In the third quarter of this year, i-SENS intends to introduce the CGM after full-scale mass production starts after the approval.

The business will also get started right away on the registration of diabetic consumables so that people with type 1 diabetes can get financial assistance when buying 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.”

Sam Draper
July 12, 2023

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