Subtle Medical Receives FDA Clearance for SubtleHD(CT) to Expand AI-Powered Image Enhancement into CT Imaging
Subtle Medical has announced 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 the company’s first product for CT and expands its 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.
CT is one of the most widely used imaging modalities in healthcare, serving as a critical tool for diagnosing and monitoring a broad range of conditions. As imaging volumes continue to grow, providers face increasing pressure to deliver consistent, high-quality imaging across diverse scanner fleets, including older systems that continue to play an important role in patient care. SubtleHD(CT) was developed to help address these challenges by enhancing image quality through AI-powered image processing that reduces noise and improves image clarity while integrating seamlessly into existing workflows.
Ohad Arazi, Chief Executive Officer of Subtle Medical, said healthcare organizations are looking for ways to improve imaging performance while maximizing the value of the infrastructure they already have. He noted that with SubtleHD(CT), the company is extending its expertise in AI-powered image enhancement to CT and taking another step toward its vision of helping providers enhance image quality across the imaging enterprise. Dr. Ajit Shankarayarayanan, Chief Product Officer of Subtle Medical, said many providers operate a mix of scanner generations and technologies across their organization, and that 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 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.
