- Campbell Arnold
- Jun 10
- 3 min read
“Given that up to 90% of stroke risk and 50% of dementia risk is modifiable, it is imperative that our healthcare networks develop infrastructure to proactively monitor brain health.”
— Johnson et al., AJNR 2025
Welcome to Radiology Access! your biweekly newsletter on the people, research, and technology transforming global imaging access.
In this issue, we cover:
Hyperfine Nets Back-to-Back FDA Clearances for Software and Next-Gen Device
AJNR Showcases the Power and Potential of Low-Field MRI
Frozen No More: FDA’s Gen AI, Elsa, Aims to Speedup The Agency’s Workflow
AI Informatics Take Center Stage at SIIM 2025 in Portland
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Hyperfine Nets Back-to-Back FDA Clearances for Software and Next-Gen Device
Hyperfine has achieved a major milestone for portable MRI, receiving back-to-back FDA clearances for its deep learning-based Optive AI reconstruction software and its next-generation Swoop system. Optive AI delivers significant improvements in resolution, contrast, and noise suppression, marking the most substantial image quality leap yet for the platform. Complementing this, the upgraded Swoop scanner introduces:
Higher gradient strength
Redesigned head coil
Improved RF shielding
More open, patient-friendly design
New symmetric yoke
These advancements not only enhance clinical performance but also support Hyperfine’s new strategy to bring MRI into neurologists’ offices, signaling a transformative step toward making low-field, portable imaging more accessible in outpatient care.
AJNR Showcases the Power and Potential of Low-Field MRI
The American Journal of Neuroradiology (AJNR) recently released a special collection on low-field MRI, sponsored by Hyperfine, highlighting its growing role in expanding access to neuroimaging—particularly in underserved and resource-limited settings. The featured studies showcase how portability can expand MRI to new use cases, including:
Assess ventricular size in acute care
Diagnose optic neuritis at the point of care
Predict white matter hyperintensities and brain health in primary care, and
Providing neuroimaging in remote or underserved regions, like Malawi.
These findings underscore the clinical potential of low-field MRI as more than a temporary solution—positioning it as a transformative tool for global health. With Hyperfine's newly cleared next-gen system and AI-powered reconstruction now available, the field is poised for even greater impact.
Frozen No More: FDA’s Gen AI, Elsa, Aims to Speedup The Agency’s Workflow
The FDA officially launched Elsa, a generative AI tool designed to streamline internal workflows. Else can help FDA staff with tasks like summarizing adverse events or reviewing clinical protocols, marking a key step in the agency’s modernization efforts. Elsa won’t directly evaluate medical products but could help expedite the review process by supporting FDA staff. For radiology AI developers, Elsa’s debut signals a more tech-savvy FDA—one that may be better equipped to understand and keep pace with emerging AI innovations, potentially improving regulatory efficiency, although also raising questions about automation bias and changes to submission practices.
AI Informatics Takes Center Stage at SIIM 2025 in Portland
SIIM 2025 in Portland brought together the imaging informatics community to spotlight the transformative role of AI and data science in medical imaging. There was a strong focus on generative AI, multi-specialty enterprise imaging, and ethical deployment frameworks. Through keynotes, demos, and collaborative sessions, attendees explored the latest tools while also emphasizing the need for rigorous validation, especially as AI advances faster than policy. The meeting blended technical innovation with a sense of community, underscored by reflections from leaders like Rohini Kosoglu, who urged attendees to actively shape the future of medical AI regulation.
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References
Mathew, Vinu, et al. "Portable Bedside Low-field MRI for Assessment of Ventricular Size." American Journal of Neuroradiology (2025).
Johnson, Ian P., et al. "Predicting White Matter Hyperintensity: Leveraging Portable Magnetic Resonance Imaging for Accessible Brain Health Screening." American Journal of Neuroradiology (2025).
Lim, Timothy Reynold, et al. "Low-Field (64 mT) Portable MRI for Rapid Point-of-Care Diagnosis of Dissemination in Space in Patients Presenting with Optic Neuritis." American Journal of Neuroradiology 45.11 (2024): 1819-1825.
Velagapudi, Vivek, et al. "Low-Field Portable MR Imaging to Evaluate Ventricular Volumes: A Single-Center Retrospective Study." American Journal of Neuroradiology 45.8 (2024): 1076-1080.
Goyal, Manu S., et al. "MRI-Based Brain Volume Scoring in Cerebral Malaria Is Externally Valid and Applicable to Lower-Resolution Images." American Journal of Neuroradiology 45.2 (2024): 205-210.
Chetcuti, Karen, et al. "Implementation of a low-field portable MRI scanner in a resource-constrained environment: our experience in Malawi." American Journal of Neuroradiology 43.5 (2022): 670-674.
Disclaimer: There are no paid sponsors of this content. The opinions expressed are solely those of the newsletter authors, and do not necessarily reflect those of referenced works or companies.
