MENLO PARK, Calif., Sept. 18, 2019 /PRNewswire/ — Subtle Medical, a privately-held healthcare technology company focused on improving the quality, efficiency, and safety of medical imaging, announced that it received a Fast-Track Small Business Innovation Research (SBIR) grant valued up to $1.6 million, contingent on deliverables, from the National Institutes of Health (NIH). This 2.5-year fast track to Phase 2 award will fund an innovative artificial intelligence (AI) product, SubtleGAD™, in development by Subtle Medical with the goal of reducing gadolinium dosage needed during MRI exams using deep learning (DL). The work will lead to safer contrast-enhanced MRI.
The low-dose contrast-enhanced MRI method will benefit not only millions of patients with advanced chronic kidney disease (CKD) who cannot currently undergo contrast-enhanced MRI, but many more patients with normal kidney function, who are at the risk of gadolinium retention after a contrast-enhanced MRI. “With SubtleGAD™ technology, hospitals and imaging centers will be able to deliver safer MRI exams without sacrificing the clinical quality of the images,” says Enhao Gong, PhD, Co-founder & CEO of Subtle Medical. “We are grateful to receive NIH’s support to further the development of our AI product and bring it into clinical use.”
Over 40 million MRI scans are performed annually. Gadolinium-based contrast agents (GBCAs) are used in approximately one-third of all MRI scans. The usage of GBCAs has been linked to the development of nephrogenic systemic fibrosis (NSF). NSF can be painful, cause severe disability, and even death. The recent identification of gadolinium deposition within the brain and body has raised additional safety concerns about the usage of GBCAs. The FDA recently issued warnings about gadolinium retention following contrast-enhanced MRI and required GBCA manufacturers to conduct human and animal studies to further assess the safety of these contrast agents.