Crescom wins FDA 510(k) for MediAI‑BA — pediatric bone‑age AI cleared

Crescom Co. Ltd. received FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone‑age analysis software that estimates bone age and predicts adult height from hand‑wrist X‑rays. The Class II device demonstrated specialist‑level accuracy in trials with a mean absolute deviation of 0.39 years and is cleared for clinical use in growth assessment and pediatric endocrinology workflows. The clearance adds to the wave of AI tools reaching the U.S. market under 510(k) pathways.