Hyperfine Receives CE Marking And UK Conformity Assessment Approval For Both Next-Gen Swoop System And Latest Advancement In Optive AI Software

This milestone unlocks Hyperfine's most significant technology innovations to date for clinicians and patients across Europe and the United Kingdom, delivering a transformative leap in image quality and a major expansion of clinical capability for European markets

Hyperfine, Inc. (NASDAQ:HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced it has received CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest advancement in its Optive AI™ software. Together, these regulatory approvals enable commercialization of Hyperfine's most advanced portable MRI technology across Europe and the United Kingdom (UK), expanding access to high-quality brain imaging at the point of care and representing a pivotal milestone in the company's international commercial growth strategy.

The next-generation Swoop® scanner, which was cleared by the FDA in the second quarter of 2025, represents a significant advancement in portable brain MRI, delivering substantial improvements in image quality, workflow, and overall user experience. The next-generation Swoop® system has generated strong customer interest in the US market, where Hyperfine has placed systems in critical care and emergency rooms of hospitals, as well as in neurology offices.

In addition, Hyperfine received European approvals for the latest advancement in its Optive AI™ software, which was cleared by the FDA in December 2025. The new software includes a new multi-direction diffusion-weighted imaging (DWI) sequence that acquires and averages images from multiple diffusion directions, similar to the method used in high-field MRI scanners. This capability produces cleaner, more consistent images that are especially valuable for stroke diagnosis, enabling better detection of small strokes and enhancing the value of the Swoop® system in acute neurological care. The software is part of the next-generation Swoop® system and is also available as a standalone software upgrade, so existing users benefit from the same powerful imaging platform.

These approvals cover markets across the European Economic Area and the United Kingdom, representing a significant global healthcare market opportunity. The Swoop® system is currently commercialized in these markets through a strong network of distributors across over a dozen countries.

Hyperfine plans to initiate commercialization of the next-generation Swoop® system and the latest Optive AI™software in Europe and the UK early in the third quarter of 2026.