Hyperfine has announced the CE-mark approval of its latest generation of artificial intelligence (AI)-powered Swoop system software under the European Medical Device Regulation (MDR).
This approval marks a significant step in positioning Hyperfine for the broad European launch of its Swoop portable magnetic resonance imaging (MRI) system, enabling “faster, high-quality MR brain imaging that supports critical diagnostic decisions across diverse healthcare settings”—as stated in a recent press release from the company.
“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 Keith Muir (University of Glasgow, Glasgow, UK). “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.”
Hyperfine secured initial CE certification for the Swoop system in 2023 and, earlier this year, significantly expanded its global distribution network with partnerships established in 13 European countries, including the five major European markets. This strategic expansion aims to enhance access to advanced portable brain MRI technology across diverse healthcare settings worldwide, according to the company. Hyperfine’s Swoop system is also US Food and Drug Administration (FDA)-cleared.
“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’s 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.”
