JLK Submits FDA Approval Application for Brain Perfusion MR Imaging Analysis Solution

JLK, an AI-based medical solution specialist company led by CEO Dongmin Kim, announced on the 12th that it has completed the application for FDA approval of its brain MR perfusion imaging analysis solution (JLK-PWI).

The JLK-PWI, for which JLK is seeking FDA approval, is a solution that automatically analyzes brain MR perfusion images and provides quantitative indicators of the core area of cerebral infarction and regions with reduced brain perfusion.

This solution operates based on diffusion-weighted MR imaging (DWI) and perfusion-weighted MR imaging (PWI), automatically analyzing essential information for determining treatment plans for acute cerebral infarction and providing it to medical professionals.

By using this solution, medical staff can quantitatively identify brain areas that can be saved through vascular recanalization, enabling accurate and rapid understanding of information necessary for deciding treatment plans for critical stroke patients. In particular, it helps improve the prognosis of acute cerebral infarction patients by enabling swift decisions on emergency surgeries (procedures), including endovascular thrombectomy (EVT) for hyperacute cerebral infarction patients.

JLK expects that the FDA approval application for JLK-PWI will create a significant impact in the U.S. medical AI market. Considering that although the total number of scans is lower than in the U.S., the proportion of MRI scans relative to cerebral infarction patients is significantly higher in Korea, it is anticipated that JLK-PWI will provide more accurate lesion predictions compared to competitors Rapid AI and Viz AI.

In a comparative study conducted last year on 414 cerebral infarction patients at Chonnam National University Hospital, Rapid AI’s product failed to detect lesions in 61.4% of all cerebral infarction patients on diffusion-weighted MR images, whereas JLK’s solution failed to detect lesions in only 1.9% of patients, demonstrating superior performance in detecting core cerebral infarction lesions.

Considering the recent trend of expanding acute cerebral infarction procedures to smaller vessels and smaller infarctions, JLK’s analysis suggests that JLK-PWI, which has strengths in detecting small lesions, will be more useful clinically in the future compared to Rapid AI’s product.

The company plans to accelerate its entry into the U.S. market by leveraging its technological lead in AI-based stroke diagnosis and further strengthen its position in the global stroke treatment market.

CEO Dongmin Kim of JLK stated, “This FDA approval application is a great opportunity to officially recognize the excellence and safety of the JLK-PWI solution,” adding, “We will make various efforts to save patients’ lives through several innovative products including JLK-PWI.”

He also said, “With the annual number of MRI scans in the U.S. reaching about 36 million, which is seven times that of Korea, we expect the growth of JLK-PWI, which operates based on MRI, to accelerate,” and added, “JLK is the world’s first company to possess a full-cycle stroke solution covering both CT and MRI, and will establish itself as a new leader in the U.S. medical AI market.”