Subtle Medical Receives FDA Clearance for SubtleHD(CT) to Expand AI-Powered Image Enhancement into CT Imaging

Subtle Medical has announced FDA clearance for SubtleHD(CT), an AI-powered image enhancement solution designed to reduce noise and improve low contrast detectability across CT imaging

The clearance marks the company’s first product for CT and expands its AI-powered imaging portfolio across MRI, PET, and CT. It is the company’s 11th FDA-cleared product and builds on technology already deployed across more than 1,300 scanners worldwide.

CT is one of the most widely used imaging modalities in healthcare, serving as a critical tool for diagnosing and monitoring a broad range of conditions. As imaging volumes continue to grow, providers face increasing pressure to deliver consistent, high-quality imaging across diverse scanner fleets, including older systems that continue to play an important role in patient care. SubtleHD(CT) was developed to help address these challenges by enhancing image quality through AI-powered image processing that reduces noise and improves image clarity while integrating seamlessly into existing workflows.

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