JLK's 'AI Prostate Cancer Diagnosis Solution' Receives FDA 510(k) Clearance

Asan Hospital and University of Missouri Jointly Develop MediHubProstate

JLK announced on the 24th that its artificial intelligence (AI) prostate cancer diagnosis solution, ‘MEDIHUB Prostate,’ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). MEDIHUB Prostate is an AI prostate cancer diagnosis solution developed by JLK through clinical trials with Seoul Asan Medical Center and the University of Missouri in the United States.

JLK's AI Prostate Cancer Diagnosis Solution 'MediHubProstate'
[Photo by JLK]

According to the International Agency for Research on Cancer, prostate cancer is one of the most common cancers among men in the Organization for Economic Cooperation and Development (OECD) countries. In fact, prostate cancer is the most common cancer among men in the United States, with a lifetime risk of latent prostate cancer reaching 40% for American men over 50 years old. Accordingly, the treatment market is expected to grow at an average annual rate of 12.4%, reaching $21.5 billion (approximately 30 trillion KRW) by 2030.

MEDIHUB Prostate provides necessary data for prostate cancer diagnosis by comprehensively analyzing multiparametric magnetic resonance imaging (mpMRI), including prostate imaging and reporting data system (PI-RADS), prostate-specific antigen (PSA) density diagnosis, and other prostate cancer-related biomarkers.

Kim Dong-min, CEO of JLK, stated, “Based on this FDA clearance, we will revise our U.S. market entry plans more aggressively,” adding, “We plan to aggressively reestablish a company-wide strategy for entering the U.S. market.”