Subtle Medical Receives FDA Clearance for SubtleHD™(CT), Expanding AI-Powered Image Enhancement into CT Imaging

New software enhances CT image quality across scanner generations, supporting radiologists with improved image clarity and consistency

MENLO PARK, Calif., June 10, 2026 /PRNewswire/ -- Subtle Medical, a leader in AI-powered medical imaging software, today 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 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.

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.

"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.

To learn more, join the upcoming webinar with AuntMinnie on June 17th at 10 AM PT / 1 PM ET, where we'll explore the clinical and operational impact of AI-powered MRI image enhancement. RSVP here: https://us02web.zoom.us/webinar/register/4517810361583/WN_f1Ww9jOQTmCNqdoV5ICjKQ

About Subtle Medical, Inc.

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized by TIME as a World's Top Healthcare Company (2025), an Nvidia Inception Award winner, and multiple times as a CB Insights GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through responsible and intelligent software. The company's solutions are deployed on over 1,300 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improve image quality, and enhance patient care without the need for new hardware. Learn more at www.subtlemedical.com.

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SOURCE Subtle Medical, Inc.