Hyperfine, a US-based health technology company, has secured CE mark approval for its latest artificial intelligence (AI)-powered Swoop system software under the European Medical Device Regulation (MDR, EU No. 2017/745).
The latest approval paves the way for the broad European launch of the Swoop Portable Magnetic Resonance Imaging (MRI) system.
Swoop portable MRI system is designed to offer fast brain imaging to support critical diagnostic decisions in various healthcare settings.
The system is also US Food and Drug Administration (FDA)-cleared for brain imaging in patients of all ages.
This portable, ultra-low-field MRI device captures detailed images of the head’s internal structure, especially in cases where full diagnostic imaging is impractical. These images can aid in diagnosis when interpreted by a physician.
The Swoop system received CE certification in the European Union (EU) in 2023 and UK Conformity Assessment (UKCA) certification. It is commercially available in select international markets.
Earlier this year, the company expanded its global reach by forming partnerships in thirteen European countries. The move aims to improve access to advanced portable brain MR imaging technology in healthcare settings worldwide.
Hyperfine chief commercial officer David Castiglioni said: “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.
“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.”
The health technology company said the latest software update for the Swoop system reduces scan times, potentially speeding up the diagnostic process in acute care settings.
This is important for time-sensitive conditions like stroke, where quick decisions can save lives. Faster acquisition times also minimise the impact of patient motion, improving image quality, Hyperfine added.
Last month, Hyperfine presented promising Swoop system data, highlighting MRI’s potential in monitoring amyloid-related imaging abnormalities in Alzheimer’s research.
