Hyperfine has enrolled its first patient in a study that aims to expand the use of the company's AI-powered Swoop portable MRI system to use contrast agents.
The Contrast Portable MR (PMR) study is a prospective, multicenter clinical effort that aims to evaluate the feasibility and visualization benefits of contrast-enhanced ultralow-field portable MRI. Results will support a future submission to the U.S. Food and Drug Administration (FDA) to expand the Swoop system’s intended use to include gadolinium-based contrast agents.
The primary objective of the study is to evaluate the visualization of brain lesions by using contrast agents with ultralow-field portable MRI. Visualization benefits will be assessed using three endpoints related to lesion appearance. The study will enroll about 70 patients across multiple U.S. sites.
