Research on the newly patented technology was published in the Journal of Magnetic Resonance Imaging (JMRI) in 2018 demonstrating feasibility, and it was highlighted by RSNA as one of the key advances of the year, winning an RSNA research prize. Subtle received a $1.6 million SBIR NIH Grant in 2019 to pursue research of SubtleGAD™, and in 2020, Phase II funding was awarded based on the results achieved during Phase I, confirming the scientific and technical merit of the research.

Several papers highlighting the clinical validation and technical aspects of the work have recently been published using the SubtleGAD™ technology. A recent study by radiologists at Tiantan Hospital was published in the journal European Radiology demonstrating improved image quality and excellent lesion detectability. Another manuscript published in Magnetic Resonance in Medicine (MRM) highlighted recent progress on the technical improvements that have been made by the company since the initial development of the patent. These clinical studies have further validated the efficacy of SubtleGAD™ and its corresponding AI technology by highlighting the generalizability across a large cohort of patients from multiple institutions acquired with various scanner models and GBCA products, and also shows significant potential and value to clinical applications.


"The diagnostic quality seen with low dose images enhanced by SubtleGAD's state-of-the-art technology has shown to be clinically equivalent to the full-dose images in our research," said Greg Zaharchuk, MD, PhD, Co-founder of Subtle Medical. "By adding novel products like SubtleGAD to their AI portfolio, centers will be able to address concerns around gadolinium contrast retention from MRI exams, providing peace of mind and ultimately better patient care."

SubtleGAD™ is the third software product under development in Subtle Medical's growing portfolio of AI technologies aimed at improving the quality, safety and efficiency of medical imaging. SubtleMR™ applies two methods of image enhancement—denoising and increasing image sharpness—to improve the image quality of standard and accelerated MRI protocols, while SubtlePET™ denoises PET images that were conducted in 1/4th of the original scan duration. Both vendor-neutral products are FDA-cleared and CE-marked and are in clinical use in multiple centers in the US and abroad.


About GBCAs
The U.S. Food and Drug Administration (FDA) required a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients' bodies, including the brain, for months to years after receiving these drugs. Many GBCAs have a black box warning linking them to the development of nephrogenic systemic fibrosis (NSF), with higher risk from repeat dosing. The more recent identification of gadolinium deposition within the brain and body has raised safety and liability concerns about the usage of GBCAs for both patients and imaging institutions. The long-term effects of gadolinium deposition are still unclear.

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