Crescom (CEO Jaejun Lee), an AI medical imaging company specializing in the musculoskeletal system, announced that its AI bone age analysis solution MediAI-BA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device.
This approval paves the way for Crescom to enter the US, the world's largest medical device market, accelerating its global expansion. Crescom currently supplies its solutions to approximately 500 hospitals and clinics both domestically and internationally.
MediAI-BA is an AI solution that analyzes pediatric and adolescent wrist X-ray images in about 5 seconds to assist in reading bone age. It has an accuracy level of mean absolute difference (MAD) of 0.39 years, which improves the diagnostic efficiency of medical staff.
MediAI-BA also provides an integrated management ecosystem that connects hospitals and homes. The results from hospital visits are linked to the "Onjaram" child growth management platform app, allowing parents to monitor and manage their child's growth, lifestyle habits, and even receive personalized feedback. This creates a seamless, data-driven care environment that links diagnosis and management.
“The FDA 510(k) approval is the official recognition of MediAI-BA’s clinical efficacy and safety by global standards,” said Lee Jae-jun, CEO of Crescom. “Going forward, we will contribute to health management throughout the entire life cycle, from growth to old age, through our musculoskeletal AI solution.”
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