GUILFORD, Conn.– Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced CE approval of its latest generation of AI-powered Swoop® system software under the European Medical Device Regulation (MDR, EU No. 2017/745). This approval marks a significant step in positioning Hyperfine for broad European launch of the Swoop® Portable MR Imaging® system, enabling faster, high-quality MR brain imaging that supports critical diagnostic decisions across diverse healthcare settings.
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.”
For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.
The Swoop® Portable MR Imaging® system is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing 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 Swoop® system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.
