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FDA clears Sora Neuroscience’s brain mapping software

June 27, 2025
in Health
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FDA clears Sora Neuroscience’s brain mapping software

Sora Neuroscience, a brain AI software company, announced it received FDA clearance for its Cirrus brain mapping software, which is used for helping neurosurgeons make clinical decisions. 

Cirrus uses functional magnetic resonance imaging (fMRI) to generate maps of vital brain networks to help physicians plan for brain surgery.

According to PLOS One, fMRI is a “tool for pre-surgical evaluation of the eloquent cortex. Resting state (rs-fMRI) enables functional localization without patient participation and can evaluate numerous functional domains with a single imaging session.”

Sora said in a statement that it has a non-exclusive distribution connection with Prism Clinical Imaging to make Cirrus available to users of Prism’s brain mapping platform. 

Sora stated that Prism workflow allows clinicians to utilize fMRI, diffusion tensor imaging (DTI) and other imaging tools to diagnose and plan treatment for brain disorders, including tumors, epilepsy and other neurological conditions. 

Loyola Medicine describes DTI as an MRI technique that measures the rate of water diffusion between cells to understand and create a map of the body’s internal structures that is commonly used to provide imaging of the brain.

“Cirrus maps can help neurosurgeons in making clinical decisions that strike the correct balance between aggressive resection and functional preservation in surgical patients,” Dr. Eric Leuthardt, a neurosurgeon at Washington University School of Medicine and cofounder of Sora Neuroscience, said in a statement. 

THE LARGER TREND

Other companies in the software brain imaging space include Hyperfine, which in May announced that the FDA cleared its Optive AI software for its Swoop system, an AI-powered portable MRI system for the brain. The software upgrade marked the tenth-generation release of Optive AI. 

In an intensive care unit, the Swoop system enables brain imaging at the point of care while eliminating the need to transport critically ill patients to radiology. 

There is extensive data on the role of MRI in evaluating multiple sclerosis (MS), which is a chronic inflammatory and neurodegenerative disease where one’s immune system attacks the central nervous system. 

Symptoms may include fatigue, tremors, motor dysfunction, nystagmus, numbness, loss of coordination or balance, disturbances in speech and vision, and cognitive impairment.

According to a study published in the journal NeuroImage, the application of structural and functional MRI techniques in patients with MS has enhanced “the understanding of the mechanisms responsible for clinical disability and cognitive impairment in this condition.”

Brain mapping structural and functional brain networks could improve the understanding of the brain structure-function relationship and of the pathophysiological aspects of neurological and psychiatric disorders.

In a study published in Neuroscience, researchers created a four-dimensional brain map that shows how MS-like lesions form, giving new insights into the earliest stages of the disease. 

Using a marmoset model rather than mice, researchers “tracked lesion development in real-time with MRI imaging, identifying vulnerable brain regions weeks before visible damage occurred.”

A significant finding was the role of a “specific type of astrocyte expressing the gene SERPINE1, which clustered near brain borders and influenced immune responses and myelin repair. These discoveries could help detect MS earlier and guide future treatments to slow or stop disease progression.”

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