JLK, a medical artificial intelligence (AI) specialist company led by CEO Kim Dong-min, announced on the 18th that its CT vascular imaging-based large vessel occlusion (LVO) detection solution 'JLK-LVO' has been designated as an innovative medical device through the integrated review process for innovative medical devices. This is the second designation as an innovative medical device following the stroke subtype classification solution 'JBS-01K,' officially recognizing JLK's stroke AI technology for its clinical innovation and excellence.
The integrated review for innovative medical devices is a system that jointly conducts ▲designation of innovative medical devices (Ministry of Food and Drug Safety), ▲confirmation of coverage under health insurance or non-coverage (Health Insurance Review & Assessment Service), ▲evaluation of innovative medical technology (Korea Health Industry Development Institute), and ▲market entry feasibility assessment (Korea Health Industry Development Institute), enabling entry into the medical field within 80 days after the announcement of innovative medical technology as either non-covered or selectively covered services.
Accordingly, JLK's medical AI solution is expected to enter the market in a non-covered form, significantly accelerating its commercialization speed.
Industry experts anticipate that this approval will lead to expanded adoption of medical AI solutions in major domestic and international hospitals, emergency medical institutions, and regional hub centers, and will serve as a strong driving force for JLK’s global strategy, which is actively advancing into the U.S. market.
The newly designated innovative medical device, JLK-LVO, is AI software that rapidly detects suspected large vessel occlusion (LVO) based on CT vascular imaging data. In stroke treatment, maintaining the 'golden time' requires fast and accurate LVO suspicion judgment, and JLK-LVO supports medical staff in making quick and precise decisions by being usable in real-time at emergency sites.
In particular, large vessel occlusion occurring in patients with acute ischemic stroke greatly affects patient prognosis and recovery depending on early treatment. Consequently, its practical use and demand in hospital settings are very high. JLK-LVO is effective in improving stroke workflows and is expected to outperform existing products in terms of marketability.
JLK expects that the designation through the integrated review for innovative medical devices will lead to a full-scale expansion of sales. Additionally, the supply of a package consisting of more than 12 comprehensive stroke AI solutions is expected to accelerate, enabling additional revenue generation.
Furthermore, JLK plans to uphold its commitment to the market by promptly advancing the integrated review process for the remaining stroke AI solutions and obtaining insurance reimbursement.
Kim Dong-min, CEO of JLK, stated, "The designation of JLK-LVO as an innovative medical device once again recognizes the AI-based early diagnosis technology and necessity for stroke. We expect to strengthen our revenue model through clinical expansion with domestic and international hospitals and anticipate sales growth through insurance reimbursement entry of additional solutions."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
