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Approvals mark a major milestone and bring the most advanced image quality to date to Swoop® system users in 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 its Optive AI™ software. These approvals, which closely follow the US FDA clearance, deliver a substantial leap in image quality for the Swoop® portable MRI system and expand international access to the latest Hyperfine AI-powered imaging software. Together, they mark a pivotal step in the company's ongoing commercial expansion across international markets.
Optive AI™ software enhances each stage of the imaging process—from noise cancellation and image acquisition to reconstruction and post-processing. The result is brain images with greater clarity, uniformity, and sharper anatomical detail. The software is fully compatible with first-generation Swoop® systems and requires no hardware modifications, enabling current users to benefit from the dramatic AI-driven image quality enhancements.
Posted In: HYPR
