Subtle Medical Announces Positive Findings from Proof-of-Concept Study with Bayer Investigating AI To Lower Gadolinium Dose in CE-MRI

MENLO PARK, Calif., Oct. 21, 2025 /PRNewswire/ -- Subtle Medical, Inc., a leader in AI-powered medical imaging solutions, today announced positive findings from a proof-of-concept (POC) study with Bayer, a leader in Radiology, evaluating Subtle Medical's investigational SubtleGAD™ technology.

The study, including 39 patients undergoing imaging of the brain, conducted across five leading U.S. sites including Mayo Clinic, MD Anderson Cancer Center, OSF St. Francis Hospital Peoria, University of Massachusetts and The Pennsylvania State University, investigated SubtleGAD™, an AI-enabled algorithm aiming to synthesize full-dose contrast-enhanced images by enhancing contrast signals in MRI using a reduced contrast agent dose, with the goal to generate diagnostic-quality images.

In the study, patients received one of two investigational reduced doses of a gadolinium-based contrast agent after an initial full-dose baseline exam. Using Subtle Medical's deep learning algorithm, synthesized full dose MR images from the reduced-dose acquisitions were compared with the standard-dose images.

Findings suggested similarity of the investigational AI-synthesized reduced-dose images when comparing lesion visualization parameter scores—contrast enhancement, border delineation, and internal morphology—with those of standard full-dose images.

"This study represents an important step forward in validating SubtleGAD™ as a tool to enable reduced gadolinium dose imaging without compromising quality," said Dr. Ajit Shankaranarayanan, Chief Product Officer at Subtle Medical. "For patients, this may mean reduced exposure; for radiologists, it may offer confidence that diagnostic information is preserved with less gadolinium dose. We're proud to collaborate with Bayer on this work, which underscores our shared commitment to advancing patient-centered innovation."

Bayer has elected to extend its collaboration with Subtle Medical into the next phase of clinical development for SubtleGAD™. The partners will now focus on conducting further clinical research to evaluate the use of SubtleGAD, potentially supporting the use of reduced gadolinium dose milestones.

The collaboration builds on Subtle Medical's growing portfolio of AI-powered image enhancement solutions, including FDA-cleared and CE-marked Subtle-ELITE™ (a comprehensive MRI package that includes three products: SubtleHD™, SubtleSYNTH™ and SubtleALIGN™) and SubtlePET™. Subtle's AI solutions are deployed on over 1000 scanners worldwide. Together with Bayer's leadership in contrast media, this partnership reflects the industry's commitment to solutions that lower the contrast agent dose while focusing on patient safety, image quality, and imaging efficiency.

About Subtle Medical
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) 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 1000 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improved image quality, and better patient care without the need for new hardware. Learn more at www.subtlemedical.com.

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SOURCE Subtle Medical, Inc.