Hyperfine Nabs CE Mark for Latest Generation Swoop System Software

Hyperfine today announced that its FDA-cleared portable magnetic resonance (MR) brain imaging system, called the Swoop system, has gained CE approval for its latest generation of AI-powered software.

The Swoop system is indicated for brain imaging of patients of all ages. The device is categorized as a portable, ultra-low-field MR device for producing images of the internal structure of the head when full examination is not clinically practical, according to the company. Updated to reduce scan times, the most recent software may enable the system to speed up the diagnostic process in acute care settings.

“CE approval of the latest generation of Swoop system software is an important advance in making rapid MR brain imaging accessible in emergency department settings across Europe,” said Dr. Keith Muir of the University of Glasgow, in the press release announcing the approval. “Our experience with the ultra-low-field Swoop system in acute stroke cases has highlighted the benefits of combining diagnostic sensitivity and specificity with portability, enabling faster diagnosis and treatment initiation than routine high-field MRI. Scan speed enhancement with this new software will further improve efficiency and patient tolerability and support critical decision-making in time-sensitive scenarios.”

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Hyperfine initially secured a CE mark for the system in 2023. Subsequently, the company has expanded its global distribution networks with partners in 13 European Union counties in 2024, including five major EU markets. The device is also UKCA certified in the United Kingdom.

“We are thrilled to announce CE approval for the latest generation of AI-powered software for the Swoop system, marking a pivotal step toward making advanced brain imaging technology accessible across the globe,” said David Castiglioni, Hyperfine chief commercial officer, in the release. “With a broad international distribution network in place and the latest software being CE-approved, we are well positioned for commercial expansion. We are committed to transforming healthcare through innovative, cost-effective solutions that address long-standing barriers to MRI access, and we look forward to expanding our collaboration with European healthcare leaders and providers to improve brain MRI access and patient outcomes across the region.”