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FDA clears Subtle Medical's PET software

Subtle Medical has secured clearance from the U.S. Food and Drug Administration (FDA) for SubtleHD(PET), an AI-powered PET image enhancement software designed to improve image quality and reduce scan times on existing PET/CT and PET/MRI systems. 

The software supports all FDA-approved molecular imaging agents and can reduce PET acquisition times by up to 75%, according to the company. It includes an adjustable denoising level and leverages anatomical CT data to improve image reconstruction quality and SUVmax quantitation accuracy, Subtle Medical said. 

SubtleHD(PET) expands on the company's existing SubtlePET platform, which is currently deployed on more than 1,300 scanners worldwide, the company noted. 

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