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BioWorld - Saturday, December 27, 2025
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Home » Crescom wins FDA clearance for bone analysis
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Crescom wins FDA clearance for bone analysis

Dec. 24, 2025
By Marian (YoonJee) Chu
Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a class II medical device, MediAI-BA evaluates bone age and suggests predicted adult height based on growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.
BioWorld MedTech Regulatory Artificial intelligence Neonatal/pediatrics Medical devices Imaging Digital health Orthopedic implants Asia-Pacific U.S. 510(k) FDA MOHW

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