JLK has announced that its AI-based perfusion imaging stroke solution, JLK-PWI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This marks the fourth FDA approval for JLK this year, highlighting the company's rapid advancement in AI-driven healthcare solutions for stroke diagnosis. The FDA's clearance allows JLK to market JLK-PWI in the United States, a significant step for the company's global expansion.
JLK-PWI: AI for Rapid Stroke Diagnosis
JLK-PWI is designed to automatically analyze brain MR perfusion images, providing quantitative indicators for brain infarction areas. This technology is crucial for the timely and accurate diagnosis of strokes, which occur when the blood supply to part of the brain is interrupted or reduced, potentially leading to brain damage, disability, or death. The FDA's 510(k) approval process ensures that new medical devices are as safe and effective as existing, legally marketed devices.
Comparative Study Demonstrates Superior Performance
The effectiveness of JLK-PWI was demonstrated in a comparative study conducted by Chonnam National University Hospital. The study revealed that JLK-PWI failed to detect lesions in only 1.9% of stroke patients, a stark contrast to Rapid AI's 61.4% failure rate. This significant difference underscores the potential of JLK-PWI to improve stroke diagnosis and patient outcomes. These findings suggest that JLK-PWI could offer a more reliable tool for clinicians in identifying stroke-affected areas in the brain.
Strategic Expansion in the U.S. Market
Kim Dong-min, president of JLK, expressed optimism about the company's future in the U.S. market. "With the FDA approval of JLK-PWI, we can widely promote the excellence of JLK's MRI solutions in the U.S. market," he stated. "We will continue to firmly establish JLK as the world's first full-cycle stroke solution provider covering both CT and MRI in the U.S. market."
The U.S. AI healthcare market, valued at approximately 21 trillion won in 2022, represents about 59% of the global market. This makes it a highly lucrative target for medical technology companies. Additionally, the U.S. medical market offers higher reimbursement rates for AI medical devices compared to Korea, providing further financial incentives for companies like JLK to seek FDA approval and market their products in the U.S.
Further Approvals and Future Plans
This approval follows a series of successful FDA clearances for JLK this year. In June, the company received clearance for its prostate cancer diagnosis solution, JLK-Prostate. This was followed by the clearance of its large vessel occlusion detection solution for stroke, JLK-LVO, in September. Most recently, in October, JLK's stroke differentiation solution, JLK-CTP, received premarket approval from the FDA. JLK-CTP aids in determining the need for surgery in stroke patients by identifying brain infarction sites from CT images.
To support its U.S. market entry, JLK raised approximately 49 billion won through a rights offering in early October. The company plans to apply for FDA approval for three additional stroke solutions within this year, further expanding its portfolio of AI-driven medical technologies.
