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.
Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also showed patients experienced a significant reduction in their pain levels.
With millions of people suffering from chronic back pain, Discure Technologies Ltd. is hoping that its bioelectronic therapy, the Discure system, will soon bring relief.