Crescom Co. Ltd. received U.S. FDA 510(k) clearance for MediAI‑BA, an AI‑powered pediatric and adolescent bone age analysis software. The device, classified as class II, estimates bone age and predicts adult height from hand‑wrist X‑rays; prior trials reported specialist‑level accuracy with a mean absolute deviation of 0.39 years. The clearance signals regulatory receptivity to narrow‑indication AI diagnostic software, accelerating adoption in pediatric endocrinology and forensic contexts while raising considerations around integration into radiology workflows and reimbursement pathways.