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
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.
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—today announced that it has received FDA clearance for its latest Optive AI™ software update. This advancement is Hyperfine’s second FDA-cleared software package since the launch of its next-generation Swoop system in mid-2025. It builds on Hyperfine’s Optive AI software to deliver even higher image quality in challenging clinical environments, a more intuitive scanning experience for Swoop system operators, and a new imaging sequence for three-dimensional visualization—further extending the clinical value of the Swoop system across care settings.
Since the Swoop system does not require the shielding that conventional high-field MRI systems depend on, it can scan in electromagnetically noisy environments, such as intensive care units and emergency departments, without sacrificing image quality. This latest advancement in Optive AI software takes Hyperfine’s proprietary noise cancellation a step further, improving noise correction across all sequences to deliver clearer, more consistent images that move closer to high-field quality, even in noisy point-of-care environments where only the Swoop system can go. The software also introduces an improved user interface with a more guided scanning workflow and lets operators view sequences and images as they're being acquired, making the system even more intuitive and easier to use.
