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Imagen Gains FDA Clearance for Fracture Diagnostic Software -

Imagen received FDA de novo clearance to market OsteoDetect computer-aided detection and diagnosis software designed to detect adult wrist fractures. OsteoDetect uses an artificial intelligence algorithm to analyze 2-D x-ray images for signs of distal radius fracture, then marks the image. It can be used in a wide range of settings: primary care, ER, urgent and specialty care, and can support early intervention in disease. (FDA.gov, 5/24/18)