Hyperfine Announces FDA Clearance of Optive AI™ Software, Introducing the Most Substantial Image Quality Improvement Ever for the Swoop® System | HYPR Stock News

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May 28, 2025
  • Hyperfine, Inc. (HYPR, Financial) announces FDA clearance for Optive AI™ software, enhancing image quality for their Swoop® portable MRI system.
  • The new AI-powered software significantly improves image clarity, making portable MRI imaging more comparable to traditional 1.5 tesla MRI scanners.
  • Hyperfine plans to roll out Optive AI™ software to new accounts by Q3 2025, aiming for expansion into neurology office markets.

Hyperfine, Inc. (HYPR), a leader in health technology innovation, has received FDA clearance for its Optive AI™ software, marking a major enhancement in image quality for its Swoop® portable MRI system. This tenth-generation software is engineered to refine every stage of the imaging process, including noise cancellation, image acquisition, reconstruction, and post-processing. The enhanced images offer greater clarity and anatomical detail, significantly advancing the diagnostic capabilities of portable MRI scans.

Initial feedback from select clinical sites indicates that the new Optive AI™ software allows brain imaging to approach the quality seen in conventional 1.5 tesla MRI scanners. This development underscores the potential for improved patient care at the point of need, a core component of Hyperfine's mission.

"The substantial image quality enhancements enabled by Optive AI™ software will serve as a catalyst for our 2025 growth strategy, supporting expansion into new hospital sites of care and our entry into the neurology office market," stated Tom Teisseyre, Hyperfine Chief Operating Officer.

Hyperfine plans to begin the rollout of Optive AI™ software to new accounts during the third quarter of 2025. This rollout aligns with their broader strategy to extend their reach into the neurology office market and beyond, further solidifying their presence in the medical imaging industry.

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