Oct. 21, 2025 — Subtle Medical, Inc., a provider of AI-powered medical imaging solutions, has announced positive findings from a proof-of-concept (POC) study with Bayer 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.
Learn more at www.subtlemedical.com.
December 03, 2025 
