Hyperfine Enrolls First Patient in Study to Expand Swoop System's Intended Use with Contrast Agents

Hyperfine has enrolled the first patient in a study to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI. The study aims to support an FDA 510(k) submission to expand the Swoop system's intended use to include gadolinium-based contrast agents. The primary objective is to assess the visualization of brain lesions using contrast agents with ultra-low-field portable MRI. The study will enroll approximately 70 patients across multiple sites in the United States.