[Special Stock] JLK, Brain CT Perfusion Imaging AI Solution Receives US FDA 510K Approval... Third This Year↑

JLK is showing strength. This is interpreted as being influenced by the news that the stroke solution JLK-CTP has obtained FDA 510(k) approval from the U.S. Food and Drug Administration (FDA).

As of 9:27 AM on the 17th, JLK is trading at 12,450 KRW, up 3.15% compared to the previous day.

JLK-CTP is a solution that automatically calculates the volume of the infarct core and perfusion deficit areas based on cerebral blood flow (CBF) analysis results from brain CT perfusion imaging.

By using this solution, it is possible to precisely identify not only the location of the cerebral infarction but also the extent of the damage, providing the range of recoverable brain tissue and the volume of the ischemic core, enabling rapid decisions on whether to perform surgery or procedures for stroke patients where every moment counts.

This approval is the third FDA approval this year following JLK-PROSTATE (prostate) and JLK-LVO (large vessel occlusion), and the company expects that the regulatory approvals for other stroke solutions they have applied for will also gain momentum. JLK completed the FDA regulatory application for the JLK-PWI (brain perfusion MR) product in August and plans to apply for three additional stroke solutions within this year.