South Korea’s JLK Inc., a developer of AI-based diagnostic solutions and platforms, announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for its prostate cancer diagnostic tool, Medihub Prostate.
Developed in collaboration with Seoul Asan Hospital and the University of Missouri, Medihub Prostate leverages AI technology to analyze prostate magnetic resonance (MR) images and assess prostate-specific antigen (PSA) levels. This innovative approach aims to improve the accuracy and efficiency of prostate cancer diagnosis.
Prostate cancer remains the most prevalent cancer among men in the United States, with a latent occurrence risk as high as 40%. The introduction of Medihub Prostate is expected to significantly enhance diagnostic capabilities and patient outcomes.
JLK’s CEO, Kim Dong-min, stated that the FDA approval marks a pivotal step for the company. “Based on the FDA approval of Medihub Prostate, we plan to pursue entry into the US market more aggressively,” Kim said. He also revealed plans to seek FDA approval for three additional AI solutions between August and October, aiming to expand JLK’s footprint in the American healthcare sector.
The approval of Medihub Prostate underscores JLK Inc.’s commitment to advancing medical diagnostics through AI, promising improved diagnostic accuracy and streamlined processes for healthcare providers in the US.
