FDA Clears Next-Generation AI-Powered PET Imaging Software
The SubtleHD(PET) software reportedly facilitates enhanced image quality, provides improved SUVmax quantitative accuracy and compatibility with all FDA-approved radiotracers.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the SubtleHD(PET) software, which may allow up to a 75 percent improvement in scan times for positron emission tomography (PET).
Subtle Medical, the developer of the software, said
• enhanced image quality;
• state-of-the-art AI model architecture;
• improved SUVmax quantitative accuracy; and
• adjustable denoising per radiologist preference.
Noting industry report projections suggesting a 67 percent increase in PET imaging volume over the next year, Subtle Medical also emphasized the compatibility of SubtleHD(PET) with all FDA-approved radiotracers.
“PET imaging demand continues to grow globally, but providers remain constrained by scanner capacity, long scan times, and operational inefficiencies,” said Ajit Shankaranarayanan, PhD, the chief product officer for Subtle Medical. "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."
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