Hyperfine has received CE approval for the latest generation of its Swoop portable MR imaging system.

This approval, granted under the European Medical Device Regulation (MDR, EU No. 2017/745), clears the way for a broader commercial launch across Europe.

The Swoop system, the first FDA-cleared portable MR brain imaging system in the U.S., enables rapid brain imaging that supports timely diagnosis, particularly critical in emergency care settings. Its portability and ultralow-field capabilities are designed to provide access to imaging in locations where conventional, high-field MR systems are impractical.
Hyperfine, based in Guilford, Connecticut, originally obtained CE certification for the Swoop system in 2023 and has since established partnerships to support distribution in thirteen European countries, including the region's largest markets.

David Castiglioni, Hyperfine’s chief commercial officer, highlighted the importance of this regulatory milestone, stating, “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.” Castiglioni emphasized the company’s commitment to overcoming barriers to MR access with innovative, cost-effective technology and expanding collaborations with European healthcare providers.

The new software improves the Swoop system’s efficiency, potentially reducing scan times and the impact of patient motion on image quality. This improvement is expected to support faster diagnostics, particularly in acute care scenarios such as stroke, where rapid imaging can make a significant difference in patient outcomes.

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