The new solution supports all FDA-approved radiotracers and enables up to 75% faster PET imaging on existing scanners

MENLO PARK, Calif., May 27, 2026 /PRNewswire/ -- Subtle Medical, a leader in AI-powered medical imaging software, today announced the FDA clearance of SubtleHD™(PET), its 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.

There are an estimated 4.5 million PET scans performed each year globally, with PET imaging continuing to expand as new tracers and theranostic workflows emerge.  Industry reports indicate that 67% of PET imaging sites expect procedure volumes to increase over the next 12 months.  As PET imaging volumes continue to grow, health systems are increasingly challenged to improve throughput, expand patient access, and maximize existing scanner capacity.

The new clearance significantly expands Subtle Medical's PET market reach, including imaging providers utilizing 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. Built on a state of the art AI model architecture, SubtleHD™(PET) provides improved image enhancement performance, greater SUVmax quantitation accuracy, and expanded compatibility across all FDA-approved radiotracers, including emerging molecular imaging agents beyond traditional 18F-FDG imaging.

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.

"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.

About Subtle Medical, Inc.

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized by TIME as a World's Top Healthcare Company (2025) and multiple times as a CB Insights GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through responsible and intelligent software. The company's solutions are deployed on over 1300 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improve image quality, and enhance patient care without the need for new hardware. Learn more at www.subtlemedical.com.

Media Contact:
Anna Menyhart-Borroni
Head of Marketing
anna@subtlemedical.com

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SOURCE Subtle Medical, Inc.