Hyperfine Inc. has won CE approval for the latest generation of its artificial intelligence-powered Swoop system software under the European Medical Device Regulation. The authorization helps position Hyperfine for a broad European launch of the Swoop Portable MR Imaging system.

Hyperfine secured initial CE certification for the Swoop system in 2023. Earlier this year, the company 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 magnetic resonance (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,” Hyperfine Chief Commercial Officer David Castiglioni said. “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 solutions that address longstanding 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 accelerate the diagnostic process in professional acute care settings, which is crucial for time-sensitive medical conditions such as stroke. 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.”

The Swoop Portable MR Imaging system is cleared by the U.S. Food and Drug Administration (FDA) 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 head’s internal structure 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.

Hyperfine is a health technology company that has redefined brain imaging with the Swoop system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine scientists, engineers, and physicists developed the Swoop system out of a passion for redefining brain imaging methodology and the ways clinicians can apply accessible diagnostic imaging to patient care.