Announcement • Aug 21

Hyperfine Announces FDA Clearance Of The Next Optive AI Software Update For The Swoop System

Hyperfine, Inc. has received FDA clearance for its latest Optive AI software update. 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. 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. This latest update debuts the isotropic T1 sequence, delivering thinner slices and equally high resolution across all imaging planes. This new capability is especially valuable in clinical situations where spatial visualization supports clinical assessment, such as post-operative tumor follow-up, and represents a new brain imaging capability now possible in the ultra-low field Swoop system. Hyperfine plans to start the rollout of this new software in the United States to existing and new Swoop system users in September.

Announcement • Aug 14

Lioness Medtech Announces Validation Of The Hyperfine Swoop Portable MRI System For Accurate Infant Brain Growth Tracking

Lioness Medtech, the nordic distributor of the Hyperfine Swoop Portable MRI system announced that the newly published, peer-reviewed research validates the portable MRI scanner as a highly accurate tool for tracking infant brain development. The study, miniMORPH: A Morphometry Pipeline for Low-Field MRI in Infants, published in Human Brain Mapping, proves that the bedside Swoop system can successfully map early brain growth and detect clinical anomalies, delivering vital developmental data without the massive costs and infrastructure required by traditional MRI machines. The bedside Swoop Portable MRI system can successfully map early brain growth and detect clinical anomalies, delivering vital developmental data without the massive costs and infrastructure required by traditional MRI machines. This makes pediatric neuroimaging accessible and affordable to a wider population of infants worldwide. Historically, infant brain development research and early neurological diagnostics have been heavily restricted to high-income regions due to the extreme costs and infrastructural demands of high-field MRI scanners. While the ultra-low-field (0.064T) Hyperfine Swoop solved the hardware accessibility problem by bringing MRI directly to the patient's bedside, existing neuroimaging software tools struggled to interpret the lower-contrast images of developing infant brains. The miniMORPH study, led by Chiara Casella and researchers at King's College London, officially bridges that gap. The researchers built and tested an open-source pipeline specifically for 0.064T pediatric scans, successfully proving that portable ultra-low-field MRI can effectively map infant brain growth and detect clinical anomalies. Brain segmentation generated by the open-source miniMORPH pipeline using ultra-low-field (0.064T) T2-weighted images from a portable Hyperfine Swoop MRI. The software accurately outlines major brain tissues and complex sub-structures across sagittal, coronal, and axial views--proving that clinical-grade developmental data can now be extracted without high-field MRI infrastructure. The study analyzed infants aged 2 to 27 months across cohorts in South Africa and Uganda. Key findings demonstrating the efficacy of the Hyperfine Swoop include: Anatomical Precision: The system successfully and reliably mapped major brain regions, capturing accurate volumetric data for gray matter, white matter, and cerebrospinal fluid. Developmental Tracking: Portable MRI scans accurately captured expected age-related brain growth trajectories over the critical first two years of life. Clinical Sensitivity: The ultra-low-field scans proved sensitive enough to detect reduced regional brain volumes and altered growth trajectories in infants born with low birth weights. For healthcare providers, global health initiatives, and regional hospitals, this validation confirms that the Hyperfine Swoop is not just a tool for fast and accessible neuroimaging, it is a robust instrument for comprehensive neurodevelopmental monitoring. The scanner plugs into a standard electrical outlet, can be wheeled directly to a crib or bedside, and requires a fraction of the investment of conventional MRI systems.

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Lioness Medtech Showcases Hyperfine Swoop Portable Mri System At Röntgenveckan 2026

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Lioness Medtech Announces Validation Of The Hyperfine Swoop Portable MRI System For Accurate Infant Brain Growth Tracking

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