Hyperfine Nets CE Mark for AI-Powered Portable MR System

Hyperfine, Inc. announced CE approval of its latest generation of AI-powered Swoop system software under the European Medical Device Regulation. Hyperfine secured initial CE certification for the Swoop system in 2023. Earlier this year, Hyperfine significantly expanded its global distribution network with partnerships established in thirteen European countries, including the five major European markets. This strategic expansion aims to enhance access to advanced portable brain MR imaging technology across diverse healthcare settings worldwide.

“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,” shared David Castiglioni, Hyperfine Chief Commercial Officer. “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.”
Scan time reductions in the most recent software may enable Swoop system images to help speed up the diagnostic process in professional acute care settings, which is crucial for time-sensitive medical conditions such as stroke, where every second counts. Reducing the overall acquisition time for sequences can also decrease the negative impact of patient motion on image quality.

“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,” shared Dr Keith Muir of the University of Glasgow. “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.”