Hyperfine wins FDA clearance for updated portable MRI software

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Hyperfine Announces FDA Clearance of the Next Optive AI™ Software, Further Enhancing Image Quality, Clinical Utility, and Ease of Use of the Swoop® System Across Care Settings

August 20, 2026 8:15 AM EDT

This newest software delivers improved image quality across Swoop system sequences, a more intuitive scanning experience, and new foundational isotropic imaging designed to strengthen the clinical utility of portable MRI.

GUILFORD, Conn.--(BUSINESS WIRE)-- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain... More