GUILFORD, Conn. — Hyperfine, Inc. (Nasdaq: HYPR), developer of the first FDA-cleared portable MRI system for brain imaging, announced it has reached a key milestone in its NEURO PMR study, enrolling its 100th patient just 16 weeks after launch. The study evaluates the clinical use and patient experience of the company’s next-generation Swoop® system in outpatient neurology settings.
The NEURO PMR study is the first multi-center, prospective observational trial comparing Hyperfine’s ultra-low-field MRI with conventional high-field MRI in a clinical office environment. It is being conducted at the DENT Neurologic Institute and Texas Neurology. All patients enrolled have been scanned using the upgraded Swoop® system, which is powered by Hyperfine’s proprietary OptiveAI™ software. Study results are expected in early 2026.
Dr. Laszlo Mechtler, Chief Medical Officer at DENT and principal investigator of the study, praised the system’s accessibility and performance. “The next-generation Swoop® system delivers impressive image quality with a simplified clinic workflow and comfortable patient experience,” he said. “This technology puts brain imaging back in the hands of neurologists—offering an affordable, easy-to-operate MRI solution without the infrastructure demands of traditional systems.”
The milestone underscores growing demand for point-of-care neuroimaging and supports Hyperfine’s expansion into private neurology practices. The company’s office pilot program previously enabled select clinics to acquire Swoop® systems, achieve IAC accreditation, and obtain reimbursement from Medicare and private payers.
“Neurologists order hundreds of MRIs annually, yet only a fraction of private practices have on-site imaging,” said Maria Sainz, Hyperfine’s President and CEO. “Our next-generation Swoop® system opens the door for more accessible brain imaging, better clinic efficiency, and improved patient care.”
To support commercial adoption, Hyperfine has partnered with NeuroNet Pro, the largest U.S. network of independent neurology practices, to promote awareness and provide resources for implementing the portable MRI system.
The Swoop® Portable MRI (V2) System is FDA-cleared for brain imaging in patients of all ages and offers real-time AI-powered analysis in environments where conventional MRI may not be feasible.
