June 10, 2026 — Subtle Medical has received FDA clearance for SubtleHD (CT), an AI-powered image enhancement solution designed to reduce noise and improve low contrast detectability across CT imaging.
The clearance marks Subtle Medical's first product for CT and expands the company's AI-powered imaging portfolio across MRI, PET and CT. It is the company's 11th FDA-cleared product and builds on technology already deployed across more than 1,300 scanners worldwide.
AI Image Enhancement
SubtleHD (CT) helps enhance image quality through AI-powered image processing that reduces noise and improves image clarity while integrating seamlessly into existing workflows.
"Healthcare organizations are looking for ways to improve imaging performance while maximizing the value of the infrastructure they already have," said Ohad Arazi, Chief Executive Officer of Subtle Medical. "With SubtleHD(CT), we're extending our expertise in AI-powered image enhancement to CT and taking another step toward our vision of helping providers enhance image quality across the imaging enterprise."
The FDA clearance represents an important milestone in Subtle Medical's evolution into a multi-modality imaging platform.
"Many providers operate a mix of scanner generations and technologies across their organization," said Ajit Shankarayarayanan, PhD, Chief Product Officer of Subtle Medical. "SubtleHD(CT) is designed to help create a more consistent imaging experience by improving image quality across a broad range of CT systems while fitting seamlessly into existing clinical workflows."
SubtleHD(CT) joins Subtle Medical's growing portfolio of AI-powered imaging solutions, including SubtleHD (MR), SubtleHD (PET), SubtleSYNTH, and SubtleALIGN. Together, these solutions support the company's vision of a vendor-neutral AI Imaging Hub that helps healthcare providers enhance image quality, optimize workflows, and maximize the value of existing imaging infrastructure across modalities.
September 21, 2026 
