JLKE, Subdural Hemorrhage Detection Solution Files FDA Approval Application in the US... 'Fifth This Year'

JLK (CEO Dongmin Kim), the first medical AI company to be listed, announced on the 27th that it has completed the FDA approval application for its CT image-based Subdural Hemorrhage analysis solution.

Subdural hemorrhage refers to a condition where a large amount of bleeding occurs due to the rupture of blood vessels connecting the blood vessels on the brain surface or between the dura mater inside the dura surrounding the brain caused by trauma. Blood accumulates in the subdural space between the brain and the dura mater, compressing the brain, and it is characterized by often accompanying brain contusions, ruptures, and intracerebral hemorrhage.

The solution submitted to the FDA this time was developed to diagnose bleeding caused by rupture of blood vessels inside the dura surrounding the brain. It is useful for diagnosis and treatment planning of emergency trauma patients transported due to trauma such as falls or traffic accidents. In the United States, millions of traffic accidents occur annually, resulting in about 40,000 deaths each year, so the utilization of this solution is also expected to be high.

In particular, subdural hemorrhage often appears relatively darker on CT compared to other types of brain hemorrhages, and it has been the brain hemorrhage type with the lowest performance reported among AI algorithms so far. JLK is expected to perfectly respond to all brain hemorrhages along with solutions specialized in brain hemorrhage type diagnosis such as JLK-ICH by solving this algorithm performance issue.

The company evaluates that the subdural hemorrhage analysis solution is optimized for the US medical field, where emergency trauma patients frequently occur, as it helps provide rapid and accurate diagnosis in emergency situations. Additionally, acute subdural hemorrhage caused by severe head trauma such as traffic accidents or assaults often results in patients arriving at the emergency room already in a coma, and if bleeding continues, it can lead to brain death. Therefore, the solution is expected to play a significant role in securing the golden time.

Including this application, JLK has completed FDA approval applications for a total of six solutions. Among them, four types?▲MEDIHUB Prostate ▲JLK-LVO ▲JLK-CTP ▲JLK-PWI?have already received FDA approval. The company plans to expedite the remaining approval procedures and additional solution applications.

Dongmin Kim, CEO of JLK, said, "With the FDA approval application for the subdural hemorrhage detection solution that helps enable fast and accurate diagnosis and treatment in emergency situations, we will tighten our grip on entering the US market." He added, "We will spare no effort in various ways to quickly secure the market, including promptly completing FDA approval applications for the remaining stroke solutions."