Subtle Medical Gains FDA Clearance for AI-Based PET Imaging Software
28 May 2026
Subtle Medical has received US FDA clearance for SubtleHD™(PET), its latest AI-powered PET image enhancement software designed to improve image quality and speed up PET imaging workflows across PET/CT and PET/MR systems.
PET imaging demand continues to rise globally as new tracers and theranostic applications become more widely used. Healthcare providers are facing increasing pressure to improve scanning capacity, reduce waiting times, and expand patient access while using existing imaging infrastructure more efficiently.
The latest FDA clearance expands Subtle Medical’s reach in the PET imaging market, including healthcare providers using advanced radiotracers, theranostics programmes, and in-house cyclotron facilities.
SubtleHD™(PET) builds on the company’s earlier SubtlePET™ platform, which is already installed on scanners in several regions worldwide. The new software uses an advanced AI model to improve image enhancement, provide better SUVmax quantitation accuracy, and support all FDA-approved radiotracers, including newer molecular imaging agents beyond traditional 18F-FDG imaging.
The software has been validated for use with accelerated low-count PET acquisitions and allows radiologists to adjust denoising settings based on their preferences. It also uses anatomical CT data to improve PET image reconstruction quality and maintain quantitative consistency.
Ajit Shankaranarayanan said growing PET imaging demand continues to create challenges related to scanner capacity, long scan durations, and operational efficiency. The company said SubtleHD™(PET) is designed to help imaging providers improve throughput, increase patient access, and make better use of existing PET infrastructure.
Shorter PET scan times may also improve patient comfort, particularly for oncology, elderly, paediatric, and critically ill patients who often find long imaging procedures difficult. Imaging providers may also benefit from the ability to increase appointment availability and improve revenue opportunities.
SubtleHD™(PET) forms part of Subtle Medical’s wider AI imaging portfolio covering MRI, PET, and CT technologies. The company is also developing an AI Imaging Hub aimed at improving workflow management, imaging quality, operational efficiency, and enterprise-wide AI adoption across healthcare systems.
Source: prnewswire.com