newsfilter
← Latest News
Business Wire·

Hyperfine Announces Completion of Enrollment in the Contrast PMR Study to Support the Submission to Expand Indications for Use of the Swoop® System with Contrast Agents

HYPR
  • Hyperfine, Inc. completed enrollment in the Contrast PMR study, a multi-center clinical trial evaluating contrast-enhanced ultra-low-field portable MRI using the Swoop system.
  • The study aims to support the first expansion of the Swoop system's FDA indications since its original clearance to include contrast-enhanced brain imaging.
  • Primary objectives include assessing visualization of brain lesions associated with blood-brain barrier disruption using gadolinium-based contrast agents.
  • Successful results could establish new applications for outpatient neurology and post-procedural imaging in operating rooms, including residual tumor assessment after resection.
  • Hyperfine plans to submit a 510(k) application to the FDA for this indication expansion by the end of 2026 following data analysis.
  • Maria Sainz, CEO, noted that established reimbursement pathways for contrast-enhanced imaging provide a foundation for broader adoption in diverse care settings.
  • The study is registered on ClinicalTrials.gov under identifier NCT07296263.