Photo: Subtle Medical
May 27, 2026 — Subtle Medical has received FDA clearance for its SubtleHD (PET), the company's next-generation AI-powered PET image enhancement solution designed to improve image quality and accelerate PET imaging workflows across PET/CT and PET/MR systems.
The new clearance significantly expands Subtle Medical's PET market reach, including imaging providers using advanced radiotracers, theranostics programs and health systems operating their own cyclotrons.
Building on the success of SubtlePET, which is already deployed on numerous scanners worldwide, Subtle's newest FDA-cleared product, SubtleHD (PET), brings improved capabilities. SubtleHD (PET) provides improved image enhancement performance, greater SUVmax quantitation accuracy, and expanded compatibility across all FDA-approved radiotracers.
SubtleHD (PET) was validated across a broad range of accelerated low-count PET acquisitions and includes the ability to adjust the denoising level to the radiologist's preference. The software also leverages anatomical CT data to further improve PET image reconstruction quality and quantitative consistency.
Image Advances
"PET imaging demand continues to grow globally, but providers remain constrained by scanner capacity, long scan times and operational inefficiencies," said Ajit Shankaranarayanan. "SubtleHD (PET) brings the latest advances in AI imaging to help address these issues and helps imaging providers improve throughput, drive new revenue, increase patient access, and maximize the value of existing PET infrastructure while delivering faster, more comfortable imaging experiences for patients."
For patients, shorter PET exams may help reduce discomfort and improve the imaging experience, particularly for oncology, elderly, pediatric, and critically ill populations who often struggle with lengthy scans. For imaging providers, shorter scan times allow for additional slot times which can significantly increase revenue for centers.
SubtleHD (PET) is part of Subtle Medical's expanding multi-modality AI imaging portfolio spanning MRI, PET and CT. As healthcare systems increasingly look for scalable AI solutions that work across existing infrastructure, Subtle Medical is building toward a broader AI Imaging Hub vision designed to accelerate, enhance, and organize imaging workflows across modalities, scanners, and health systems. The company's long-term goal is to create a unified AI infrastructure layer for medical imaging that helps providers improve operational efficiency, standardize imaging quality, expand patient access, and scale AI adoption enterprise-wide.
September 15, 2026 
