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Hyperfine Announces FDA Clearance of the First Optive AI™ Software Update with Advanced Diffusion Imaging Capability, Focused on Enhancing Stroke Detection with the Swoop® System

GUILFORD, Conn., December 15, 2025--Hyperfine secures FDA clearance for new DWI sequence, significantly expanding the Swoop® system's clinical capabilities in acute neurological care.

articleHyperfine, Inc.December 15, 20256/company/hyperfine-inc/news/hyperfine-announces-fda-clearance-first-131500175
Hyperfine Announces FDA Clearance of the First Optive AI™ Software Update with Advanced Diffusion Imaging Capability, Focused on Enhancing Stroke Detection with the Swoop® System

About this update from Hyperfine, Inc.

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