Hyperfine Receives FDA Clearance for Portable MRI Scanner

Hyperfine has received FDA clearance for its Swoop system, which includes a new portable MRI scanner powered by the Optive AI software. The system is designed to provide a better experience for clinicians and patients across various care settings. Hyperfine's CEO, Maria Sainz, believes the new Swoop system will drive faster adoption and enhance performance for patients and providers.

Hyperfine, Inc. (Nasdaq: HYPR) has received FDA clearance for its latest innovation in portable MRI technology, the Swoop system. This clearance includes a new portable MRI scanner powered by the proprietary Optive AI™ software, marking a significant advancement in brain imaging capabilities [1].

The new Swoop® system combines powerful AI with a reimagined portable MRI platform, delivering the highest level of image quality, functionality, and usability to date. Key features include improved signal-to-noise ratio, enhanced resolution, and faster acquisition times, making it a transformative tool for clinicians and patients across various care settings [2].

Maria Sainz, President and CEO of Hyperfine, believes the new Swoop system will drive faster adoption and enhance performance for both patients and providers. The system's user-centric design accommodates a broad patient population, including pediatric, elderly, and anxious patients, making MRI more accessible [2].

The new Swoop® system is currently being used in the NEURO PMR study, which has reported positive feedback from both users and patients. Dr. Laszlo Mechtler, Medical Director of Dent Neurologic Institute and principal investigator of the NEURO PMR study, noted that the new system marks a remarkable advancement in image quality while maintaining an affordable and compact design [2].

Hyperfine's mission to revolutionize patient care globally through accessible diagnostic imaging is taking a significant step forward with this launch. The company aims to broaden adoption across critical care, emergency, and clinic settings in hospitals, neurology offices, and remote and rural care environments [2].

The new Swoop® system is expected to accelerate Hyperfine's strategy to make high-quality brain imaging more accessible, efficient, and impactful wherever patients are. For more information, visit HyperfineMRI.com.

References:
[1] https://www.joplinglobe.com/region/national_business/hyperfine-announces-fda-clearance-of-a-new-next-generation-swoop-system-powered-by-optive-ai/article_2f4a3715-6882-5d3c-a6f3-c20b8940255c.html
[2] https://www.businesswire.com/news/home/20250602409384/en/Hyperfine-Announces-FDA-Clearance-of-a-New-Next-Generation-Swoop-System-Powered-by-Optive-AI-Software-Delivering-a-Transformative-Leap-in-Image-Quality