Hyperfine Receives FDA Clearance of Optive AI Software

tim.hodson

Thu, 05/29/2025 – 16:38

Hyperfine, Inc., producer of the world’s first FDA-cleared AI-powered portable MRI system for the brain — the Swoop system — has announced FDA clearance of its next-generation software.
This tenth-generation release delivers a substantial increase in image quality for ultra-low-field MR imaging. Optive AI software enhances each stage of the imaging process   — from noise cancellation and image acquisition to reconstruction and post-processing. The…

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