Hyperfine has commercially launched its next-generation Swoop portable magnetic resonance imaging (MRI) system (Model 2) in select European markets.
The company stated that this follows both CE mark and UK Conformity Assessed (UKCA) approval for the device.
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The introduction of Model 2 into Europe aims to support Hyperfine’s international commercial objectives and enhance access to brain imaging at the point of care.
Swoop is powered by Hyperfine’s updated Optive AI software, featuring improved image quality, workflow efficiency and clinical capabilities compared to previous versions.
European clinicians and hospitals can purchase the new system, which joins an initial wave of markets since regulatory clearance was achieved.
In addition, Hyperfine has confirmed that the Swoop system is included in the Union of Hospitals for Procurement (UniHA) listing, enabling a wider presence within the French public healthcare system. The system’s initial listing in UniHA occurred in October 2025.
Hyperfine international vice-president Eric Willis said: “The next-generation system delivers significant improvements in image quality, workflow efficiency and clinical capability. We have already seen these advancements accelerate use and adoption of the Swoop system throughout the US.
“We look forward to working closely with our distribution partners to expand access to AI-powered portable MRI across Europe, providing critical neuroimaging that helps clinicians make more timely and more informed patient care decisions.”
The European launch adds to recent developments for the company, including its inclusion in the Russell 2000 Index.
Hyperfine describes its Swoop Portable MR Imaging Systems as ultra-low-field, mobile devices cleared by the US Food and Drug Administration for brain imaging in patients of all ages.
When interpreted by trained clinicians, images from the system may assist with diagnostic decision-making, especially in settings where conventional MRI is not practical.
In October 2025, Hyperfine enrolled the first subjects in the PRISM PMR trial, which aims to assess the application of the Swoop MRI system within the operating room during neurosurgical procedures.
