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Hyperfine MRI Study Boosts Brain Lesion Clarity
16 Sep
Summary
- Study investigates contrast-enhanced MRI for better brain lesion visibility.
- Hyperfine aims for expanded FDA indication for its Swoop MRI system.
- Swoop MRI system offers portable brain imaging for all ages.
Hyperfine has concluded patient enrollment for its multi-center Contrast PMR study. This study evaluates the use of contrast-enhanced, ultra-low-field magnetic resonance imaging (MRI) with the company's portable Swoop MRI system.
The research specifically focuses on the Swoop system's capability to visualize lesions linked to blood-brain barrier disruption, such as those found in brain tumors and inflammatory conditions. The use of gadolinium-based contrast agents is central to this enhanced visualization.
Hyperfine plans to leverage the study data to support its initial submission for an expanded indication of the Swoop system, following its original FDA clearance. A 510(k) application is anticipated by the end of this year, after thorough image review and data analysis.
Company leadership expressed optimism, believing contrast-enhanced imaging could significantly drive adoption of the Swoop system. They foresee expanded use in outpatient settings and new applications in surgical environments, including post-procedural assessments. The Swoop portable MRI systems currently hold FDA clearance for brain imaging across all age groups.
