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Hyperfine Secures FDA Clearance For Next-Gen AI-Powered Portable MRI Scanner

Author: Benzinga Newsdesk | June 02, 2025 08:18am

This major Swoop® system scanner redesign and Optive AI™ software elevate the AI-powered portable MRI experience for clinicians and their patients across multiple sites of care.

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—announced today FDA clearance of its most significant technological advancement to date. Theclearance includes an entirely new portable MRI scanner powered by the proprietary Optive AI™software. This new system delivers the highest level of image quality, functionality, and usability to date, unlocking a new brain imaging paradigm for clinicians and their patients.

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