FDA Clears MediAI-OA: AI Software for Knee Osteoarthritis Assessment on Radiographs

FDA cleared MediAI-OA (Crescom Co.), an AI-based software device designed to assist in the assessment of knee osteoarthritis on radiographs. The device provides automated analysis of joint space narrowing and other OA-related features.

• Device: MediAI-OA, a software device from Crescom Co., Ltd.
• Purpose: Computer-aided detection and diagnosis software for radiological image analysis of knee osteoarthritis.
• Regulatory details: Received 510(k) clearance under product code QIH (Radiological image processing software); specific predicate device and performance metrics were not detailed in the provided source.

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