Hyperfine, whose Swoop system is the first FDA-cleared AI-powered portable MRI system for the brain, has launched the device in Europe. Following CE mark and UKCA approval, the next-generation Swoop system, also known as Model 2, is now commercially available across an initial wave of European markets.

Swoop is an AI-powered, portable brain MRI that uses a magnet with an ultra-low field strength to produce images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis, the company said.

The improvement in image quality in the next-generation Swoop system is “transformative,’’ said Steve Williams, professor of neuroimaging at King’s College London and head of the Department of Neuroimaging at the Institute of Psychiatry, Psychology & Neuroscience. “I’ve been involved with Hyperfine since the earliest days of portable MRI, and the relentless progress has been remarkable.”

Williams, who went on to say that he has spent his career exploring advanced brain imaging, added that he is “impressed that low-field MRI can provide this level of diagnostic-quality images.” For years, limited access to neuroimaging has delayed diagnosis and treatment for countless patients around the world.”

The Swoop system addresses that gap, and makes MRI accessible when and where it is needed, even in remote locations, to support decision-making in a wider range of care settings across the lifespan, Williams said.

Hyperfine also announced the inclusion of its next-generation Swoop system (Model 2) in the UniHA procurement listing, a key milestone enabling broader adoption across hospitals within the French public healthcare system. The initial inclusion of the Swoop system in this listing was in October 2025.

“We are proud to bring Hyperfine’s most advanced portable MRI technology to clinicians across Europe and the UK, delivering on an important milestone for our commercialization strategy in 2026,” said Eric Willis, vice president of international at Hyperfine. “The next-generation system delivers significant improvements in image quality, workflow efficiency, and clinical capability.”

The company has already seen these advancements accelerate use and adoption of the Swoop system throughout the United States, Willis said. Hyperfine will now work with its distribution partners to expand access to AI-powered portable MRI across Europe, with the goal of providing critical neuroimaging that helps clinicians make more timely and more informed patient care decisions.

By the end of the year, Hyperfine aims to make the Model 2 Swoop system available through its distribution partners across all European markets where Hyperfine is represented.

The European commercial launch adds to Hyperfine’s recent corporate momentum, including its inclusion in the Russell 2000® Index, as the company continues to expand global access to its AI-powered portable MRI technology.