Sora Neuroscience Announces FDA Clearance of Cirrus Resting State fMRI Brain Mapping Software

Sora's FDA clearance of Cirrus simplifies fMRI generation of eloquent cortex maps for surgical planning.

MINNEAPOLIS, MN, UNITED STATES, June 20, 2025 /EINPresswire.com/ -- Sora Neuroscience, Inc., an emerging brain AI software company working to improve patient care using resting-state functional MRI technology, today announces the FDA clearance of its Cirrus brain mapping software. While strong evidence exists for the scientific merits and potential clinical benefits of resting-state fMRI in neurologic care, there are few reliable solutions available for routine clinical use. Cirrus is a crucial radiologic advance that simplifies fMRI image acquisition and generates useful maps of critical brain networks for brain surgery planning.

"Cirrus maps can help neurosurgeons in making clinical decisions that strike the correct balance between aggressive resection and functional preservation in surgical patients," said Dr. Eric Leuthardt, MD, a neurosurgeon at Washington University School of Medicine (WashU Medicine) and Co-Founder of Sora Neuroscience. “Cirrus has the potential to increase the accuracy and reliability of functional MRI mapping and can make fMRI more widely available to patient populations, including pediatric patients,” added Joshua Shimony, MD, PhD, a neuroradiologist at WashU Medicine’s Mallinckrodt Institute of Radiology, and an advisor to Sora Neuroscience.

Cirrus was developed and clinically investigated at WashU Medicine, a recognized leader for decades in using resting-state brain activity to map brain function and better understand neurologic disease. “Sora’s on-going collaboration with WashU Medicine researchers is a significant advantage in our being able to bring products like Cirrus to market,” said Steve Schaefer, Sora’s Chief Executive.

“While advancing the standard of patient care, we’ve also kept a focus on efficient workflow and cost-of-care considerations," Schaefer added. Specifically, Cirrus is designed for plug-and-play integration into existing imaging and neurosurgery platforms. Its output brain maps are configured to be easily loaded onto a hospital’s surgical navigation platform of choice, for seamless integration of Cirrus maps for display and analysis with existing surgical planning systems.

Sora has a non-exclusive distribution relationship with Prism Clinical Imaging, Inc., of Elm Grove, WI (Prism), to make Cirrus available to users of Prism’s leading brain mapping platform. The Prism workflow provides clinicians with fMRI, DTI, and other imaging tools to diagnose and plan treatment for brain disorders including tumors, epilepsy, and other neurological disorders. Deployment options range from on-premises to cloud-based. Sora’s distribution relationship with Prism offers users access to an integrated combination of high-quality, FDA-cleared task-based and resting-state fMRI mapping solutions.

About Sora Neuroscience, Inc.

Sora Neuroscience, Inc. is an emerging brain AI software company committed to providing clinically useful and rigorously tested resting state functional MRI analysis tools ready to be integrated into existing clinical workflows. Sora was founded by leading resting state fMRI innovators at Washington University in St. Louis (WashU) working alongside a team of medical software professionals, and is headquartered in Minneapolis, Minnesota. For more information, please visit www.soraneuroscience.com.

Stephen R. Schaefer
Sora Neuroscience, Inc.
steve@soraneuroscience.com
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