Hyperfine Enrolls 1st Patient in Contrast PMR Study

Hyperfine announced the enrollment of the first patient in its Contrast PMR study.

The prospective, multi-center clinical study will evaluate the feasibility and visualization benefits of contrast-enhanced, ultra-low-field portable MRI. The study is meant to support a future U.S. Food and Drug Administration (FDA) submission to expand the Swoop system’s intended use to include gadolinium-based contrast agents.

The study’s main objective is to evaluate brain lesion visualization, including lesions with blood-brain barrier disruption, using contrast agents with ultra-low-field portable MRI. The visualization benefits will be assessed using three endpoints related to lesion appearance.

“Portable MRI has already changed how and where we image the brain at our center, and incorporating the use of contrast is a natural next step,” said Mark Anderson, MD, chief medical officer at the CHRISTUS Mother Frances Hospital study site. “Contrast-enhanced MRI is important for evaluating many neurological conditions, and we are looking forward to participating in this study to assess contrast-enhanced imaging with the Swoop system. This could further expand Swoop system utility and transform how we diagnose and monitor brain conditions.”

The study will enroll about 70 patients across multiple U.S. sites.

“Seeing contrast at ultra-low field strengths is an exciting expansion opportunity for the utility of the Swoop system,” said Hyperfine COO Tom Teisseyre, Ph.D. “The ability to use gadolinium-based contrast agents could enhance its clinical utility, particularly in cases where contrast is commonly used, such as brain tumors, suspected abscesses, and inflammatory conditions like multiple sclerosis. With the Contrast PMR study enrolling, we anticipate submission to the FDA for indication expansion towards the end of 2026.”

Last month, the company earned FDA clearance for a new multi-direction diffusion-weighted imaging (DWI) software sequence for its Swoop AI-powered, portable MRI system for the brain. The new DWI sequence acquires and averages signals from multiple directions—similar to the method used in high-field MRI scanners—to generate clean, consistent images.