Hyperfine Inc. Secures CE Mark and UKCA Approval for Optive AI™ Software, Expanding European Reach of Swoop® MRI System
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Hyperfine Inc. has received CE Mark and UKCA approval for its Optive AI™ software, enhancing the image quality of its Swoop® portable MRI system. These approvals will expand access to Hyperfine’s AI-powered imaging software in the European Economic Area and the UK, supporting the company’s global expansion. Deployment to current Swoop® system users in these regions is set to begin in Q4 2025.
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