FDA Clearance Granted to Subtle Medical's SubtleHD™(PET) for Improved Imaging

Subtle Medical has received FDA clearance for its cutting-edge AI-powered software, SubtleHD™(PET), designed to enhance PET imaging capabilities. This development is aimed at improving image quality and accelerating PET scan processes across PET/CT and PET/MR systems.

Annually, an estimated 4.5 million PET scans are performed globally. As the use of PET imaging continues to rise with the introduction of new tracers and theranostic applications, about 67% of PET facilities anticipate an increase in procedure volumes over the next year. This growth places strain on health care systems that are working to optimize scanner usage, improve patient accessibility, and increase throughput.

The recent FDA clearance of SubtleHD™(PET) broadens Subtle Medical's presence in the PET market, benefiting facilities that utilize advanced radiotracers, engage in theranostic programs, and operate their own cyclotrons. SubtleHD™(PET) builds upon the successful deployment of SubtlePET™, currently in use on many scanners worldwide. The new product offers state-of-the-art AI capabilities designed to enhance image quality, improve SUVmax quantitation accuracy, and ensure compatibility across all FDA-approved radiotracers, beyond traditional 18F-FDG imaging.

Validated through a range of accelerated low-count PET acquisition setups, SubtleHD™(PET) allows for denoising adjustments according to radiologist preferences. The software's integration of anatomical CT data contributes to enhanced image reconstruction and quantitative consistency.

Ajit Shankaranarayanan of Subtle Medical noted that as global demand for PET imaging continues to grow, providers face challenges such as limited scanner capacity, long scan durations, and operational inefficiencies. SubtleHD™(PET) is designed to address these concerns by improving imaging throughput, enhancing revenue opportunities, increasing patient access, and maximizing the use of existing PET infrastructure. Additionally, this advancement promises more comfortable imaging experiences for patients, by reducing the duration of PET exams—a particular benefit for oncology patients, as well as elderly, pediatric, and critically ill individuals.

SubtleHD™(PET) is a key feature of Subtle Medical's AI imaging portfolio, which spans MRI, PET, and CT modalities. As health systems seek scalable AI solutions adaptable to current infrastructures, Subtle Medical aims to develop a comprehensive AI Imaging Hub to enhance and streamline workflows across various modalities and systems. The goal is to create a unified AI infrastructure for medical imaging that enhances operational efficiency, standardizes imaging quality, expands patient access, and promotes AI adoption on a broader scale.