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Hyperfine receives CE Mark, UKCA approval for Optive AI

Hyperfine (HYPR) announced it has received CE Marking and UK Conformity Assessment approval for its Optive AI software. These approvals, which closely follow the 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.

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