South Korea approves first local CGM device

The South Korean Ministry of Food and Drug Safety has approved the first locally-developed continuous glucose monitoring device.

The CareSens Air, developed by blood glucose device maker i-SENS, is touted to be the smallest and lightest CGM device available in South Korea. It can also be used for 15 days straight and features a calibration mechanism to make readings more reliable. 

Following this approval, i-SENS plans to proceed with mass-scale production and targets to launch the device in the third quarter of the year. CareSens Air is also the fourth CGM device that has been approved by the South Korean government, following approvals for foreign products by Medtronic, Abbott, and Dexcom.

Moreover, i-SENS is currently seeking a CE clearance for its CGM offering, eyeing to market the product in Europe by the first half of 2024. 

THE LARGER TREND

i-SENS came up with the first iteration of the CareSens Air in 2019. Three years later, it developed its second and current iteration, which is smaller and has more enhanced compatibility with peripheral devices. 

After two decades of existence, i-SENS recently started its moves to go global with an M&A strategy. This month, the company completed its acquisition of American blood glucose device company AgaMatrix. Through this acquisition, i-SENS will be able to leverage AgaMatrix’s existing distribution channels, including leading drug distributors like CVS Pharmacy in the United States and Sanofi and Alliance Healthcare in Europe. This is its second international acquisition following its purchase of California-based CoaguSense, which develops PT/INR monitoring systems.