Subtle Medical Receives FDA Clearance for SubtleHD PET Imaging Software

May 27, 2026
Subtle Medical has received FDA clearance for SubtleHD PET, its AI-based PET image enhancement software designed to improve image quality and accelerate PET imaging workflows across PET/CT and PET/MR systems.

Subtle Medical announced in a press release that it has received FDA clearance for SubtleHD PET, an AI-based image enhancement and acceleration software for PET imaging. The solution aims to improve image quality and streamline workflows across PET/CT and PET/MR systems.

The software builds on Subtle Medical's existing SubtlePET platform and introduces improved image enhancement performance, higher SUVmax quantitation accuracy, and compatibility with all FDA-approved radiotracers, including newer molecular imaging agents. It can also adjust denoising levels to suit radiologist preferences and uses anatomical CT data to improve PET reconstruction quality.

SubtleHD PET was validated across a wide range of accelerated low-count PET acquisitions. The company states that the software enables shorter scan times, which can increase patient throughput and scanner utilization while improving patient comfort. SubtleHD PET is part of Subtle Medical's broader AI imaging portfolio covering MRI, PET, and CT modalities.

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