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
Hyperfine completed enrollment in its Contrast PMR study, a prospective, multi-center clinical study evaluating contrast-enhanced ultra-low-field brain imaging with the Swoop portable MRI system and commonly administered gadolinium-based contrast agents. The study is intended to support the first expansion of the Swoop system's indications for use since its original FDA clearance, with a planned FDA 510(k) submission by the end of 2026.
Key figures
- Nct id
- NCT07296263
- Study design
- prospective, multi-center clinical study of contrast-enhanced ultra-low-field portable MRI
- Contrast agent class
- gadolinium-based contrast agents
- Planned 510k submission
- by the end of 2026
AI analysis
Red flags3 · Pro
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.