Crescom Co. Ltd. received FDA 510(k) clearance for MediAI‑BA, its AI‑powered software that evaluates pediatric and adolescent bone age and predicts adult height from hand and wrist X‑rays. The device was classified as a class II medical device after trials showed specialist‑level accuracy with a mean absolute deviation of 0.39 years. The clearance positions Crescom to commercialize an AI diagnostic for growth assessment in pediatrics and could accelerate adoption of automated musculoskeletal imaging tools. Hospitals and pediatric endocrinology clinics evaluating AI for workflow efficiency will monitor real‑world performance, integration with PACS and reimbursement pathways for algorithm‑aided reads.
Get the Daily Brief