Cirrus Resting State fMRI Software

by Sora Neuroscience  · Based in United States → — Improving brain patient care using resting-state fMRI technology.
Neurology Neurosurgery Radiology
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Regulatory Status Disclosed

Overview

Sora Neuroscience, Inc. is an emerging brain AI software company dedicated to providing clinically useful and rigorously tested resting-state functional MRI (fMRI) analysis tools. The company strives to improve brain patient care by leveraging resting-state fMRI technology developed and clinically investigated at Washington University in St. Louis (WashU) over the past decade.

Its flagship product, Cirrus Resting State fMRI Software, is an AI-based technology that rapidly maps the brain to locate sensitive areas controlling speech, vision, movement, and other critical functions. This software has received authorization from the Food and Drug Administration (FDA) to enhance the precision of neurosurgeries.

Cirrus is designed for plug-and-play integration into existing imaging and neurosurgery platforms, with its output brain maps easily loaded onto a hospital’s surgical navigation platform of choice for seamless integration with existing surgical planning systems. The technology broadens the use of fMRI mapping to patient populations unable to perform task-based fMRI, including children and cognitively impaired patients, and offers a lower failure rate compared to traditional task fMRI.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based brain mapping algorithms
  • Resting-state fMRI analysis
  • Rapid brain function mapping (as few as 12 minutes)
  • Identifies motor, language, and vision networks
  • Simplifies fMRI image acquisition
  • Automated post-processing
  • Plug-and-play integration with existing platforms
  • Output in DICOMu00ae format for surgical navigation systems
  • Expands fMRI access to patients unable to do task-based fMRI
  • Lower failure rate compared to task fMRI

Use Cases

  • Pre-surgical brain mapping for tumor resection
  • Pre-surgical brain mapping for epilepsy treatment
  • Enhancing precision in neurosurgical procedures
  • Treatment planning for neurological disorders
  • Targeting for repetitive transcranial magnetic stimulation (rTMS)
  • Functional localization for pediatric and cognitively impaired patients

What Physicians Need to Know

Brain MRI Analysis
Cirrus processes individual patient brain MRI datasets, including blood oxygenation level dependent (BOLD) functional MRI (fMRI) data and structural MRI data. It also integrates with Diffusion Tensor Imaging (DTI) through partnerships.
Seizure Detection (for Epilepsy Planning)
The software assists in planning treatments for brain disorders, including epilepsy, by providing functional brain maps to guide neurosurgical decisions.
Neurodegenerative Disease Screening
While primarily focused on surgical planning, the underlying resting-state fMRI technology and research from its development at Washington University in St. Louis suggest its potential for understanding and potentially serving as a biomarker in neurodegenerative diseases like dementias and Parkinson's disease.
Efficiency of Functional Mapping
Cirrus utilizes AI-based algorithms to analyze patterns of linked activity in a resting brain, completing the mapping of multiple brain networks from as few as 12 minutes of fMRI, a significant reduction from typical methods that can take up to an hour.
Physician Tip

Cirrus Resting State fMRI Software simplifies the generation of eloquent cortex maps for surgical planning, offering functional localization without requiring patient participation, which expands its applicability to a broader patient population, including pediatric or cognitively impaired individuals. It provides detailed insights into brain function, enabling neurosurgeons to make informed decisions that balance aggressive resection with functional preservation. The software boasts a lower failure rate compared to traditional task-based fMRI and delivers output maps in DICOM format for seamless integration with existing surgical planning systems.

Cirrus is designed for 'plug-and-play' integration into existing imaging and neurosurgery platforms, with its output brain maps easily loaded onto a hospital's surgical navigation platform of choice. Sora Neuroscience has a non-exclusive distribution agreement with Prism Clinical Imaging, making Cirrus accessible to users of Prism's brain mapping platform, which provides an integrated workflow for fMRI, DTI, and other imaging tools. The software is built to integrate with trusted physician tools through open standards, and deployment options can range from on-premises to cloud-based.

Details

Category Neurology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — Not available
DeploymentOn-premises; Cloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Cirrus Resting State fMRI Software received FDA clearance (K251009) on June 6, 2025, as a Class II medical device (Product Code QIH). It is authorized for marketing to hospitals to enhance the precision of neurosurgeries by mapping critical brain functions.
Integrations
EHR Not specified
Specialties Neurology, Neurosurgery, Radiology

What the Web Says

Cirrus Resting State fMRI Software, developed by Sora Neuroscience, is generally perceived as a promising tool for analyzing resting-state fMRI data, particularly for its potential in aiding neurological diagnostics and research. Reviewers highlight its user-friendly interface and advanced analytical capabilities as key strengths, though some note the nascent stage of the company and the need for broader adoption and long-term validation.

Overall: Positive

Strengths

  • User-friendly interface for fMRI analysis
  • Advanced analytical capabilities for resting-state data
  • Potential for aiding neurological diagnostics and research
  • Focus on objective biomarkers for brain disorders
  • Integration with existing fMRI workflows
  • Strong scientific foundation from a reputable institution

Limitations

  • Relatively new software, less established in the market
  • Limited number of independent, in-depth reviews available
  • Pricing information not readily transparent on the website
  • Requires specialized fMRI data, not for general use
  • Potential learning curve for users unfamiliar with fMRI analysis
  • Long-term efficacy and widespread clinical validation still emerging

Based on reviews from: Sora Neuroscience Official Website, LinkedIn (Sora Neuroscience), Academic publications citing Sora Neuroscience's work, Neurology/Radiology forums (general discussions on fMRI software), Tech review sites (general fMRI software comparisons), Reddit (discussions on fMRI analysis tools)

Last updated: 2026-07-19

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Press & Coverage

WashU Medicine
AI-based brain-mapping software receives FDA market authorization
Washington University School of Medicine in St. Louis announced that their AI-based Cirrus Resting State fMRI Software, developed to enhance precision neurosurgery, has received FDA market authorization. The software, marketed by Sora Neuroscience, can map critical brain functions in as little as 12 minutes, improving accessibility for patients unable to undergo traditional task-based fMRI.
2025-06
Neurosurgery News
AI-based brain-mapping software receives FDA market authorization
The FDA has authorized an AI-based brain-mapping software program, Cirrus Resting State fMRI, developed by Eric Leuthardt, MD, at WashU Medicine and marketed by Sora Neuroscience. This technology aims to improve neurosurgery procedures by rapidly mapping sensitive brain areas controlling speech, vision, and movement.
2025-06
Research Nester
Neurosurgery Software Market Size | Growth Report 2035
A market report highlights that in June 2025, WashU Medicine decided to market Sora Neuroscience's AI-driven Cirrus Resting State fMRI software, following its FDA clearance. The software is designed to improve the accuracy of neurosurgery by identifying essential brain regions, with the goal of enhancing outcomes for tumor and epilepsy surgeries.
2025-09
accessdata.fda.gov (FDA)
FDA K251009 - 510(k) Premarket Notification
This FDA 510(k) Premarket Notification details the Cirrus Resting State fMRI Software by Sora Neuroscience, Inc. It outlines the applicant, contact information, regulation number, and classification as a medical image management and processing system.
2026-04
NeuromedHub
Artificial Intelligence in Clinical Neurophysiology: Current Advances, Challenges, and Future Perspectives - NeuromedHub
The FDA clearance of Cirrus Resting State fMRI Software in 2025 is cited as an example of AI's expanding role in functional brain mapping for neurosurgical planning. The article discusses the integration of AI in clinical neurophysiology, including multimodal data integration and regulatory frameworks.
2025-10
Hope Brain & Body Recovery Center
Neuro AI in Pediatric Neurology: What Parents and Doctors Need to Know in 2026
The Cirrus Resting State fMRI Software is highlighted as an FDA-approved system that maps brain networks in just 12 minutes, proving particularly valuable for children who cannot perform task-based scans. The article discusses the impact of Neuro AI in pediatric neurology, including faster diagnoses and personalized treatment plans.
2026-02
FDA
CDRH Premarket Authorizations that Used Real-World Evidence | FDA
The FDA lists Cirrus Resting State fMRI Software (K251009) by Sora Neuroscience, Inc. as a premarket authorization that utilized real-world evidence. Medical record data described in two peer-reviewed publications served as a primary source of clinical evidence for its clearance.
2026-06
accessdata.fda.gov (FDA)
June 6, 2025 Sora Neuroscience, Inc. John Smith Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washi - accessdata.fda.gov
This FDA document provides a 510(k) summary for the Cirrus Resting State fMRI Software, describing it as software as a medical device (SaMD) that performs image processing, resting state functional magnetic resonance imaging analysis, and output generation. It also details the software's components and its intended use.
2025-06

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Frequently Asked Questions

Yes, Cirrus Resting State fMRI Software by Sora Neuroscience, Inc. received FDA clearance (K251009) in June 2025 as a Class II medical device (SaMD). While specific HIPAA details for Cirrus are not publicly detailed, as a medical device, it operates within federal regulatory frameworks like HIPAA for protected health information, and deployment options include both on-premises and cloud-based solutions which necessitate robust data security measures.
Cirrus is designed for 'plug-and-play' integration into existing imaging and neurosurgery platforms, generating task-analogous motor, language, and vision resting state fMRI correlation maps in DICOM format. These maps can be easily loaded onto surgical navigation systems, providing critical insights for surgical planning by helping neurosurgeons balance aggressive resection with functional preservation.
Cirrus simplifies fMRI acquisition and offers fully automated post-processing, making it accessible for patients unable to perform traditional task-based fMRI, such as children or those with cognitive impairments. It boasts a lower failure rate (13%) compared to task-based fMRI (38.5%), enhancing reliability in clinical settings.
Cirrus maps have shown variability in normal subjects during repeat MR acquisitions when no functional change was expected, and the software is intended as an adjunctive tool, not a replacement for direct functional mapping procedures. General AI algorithms can also be susceptible to biases if trained on 'off-label' or pre-processed datasets, potentially leading to overly optimistic results.
Specific pricing details for Sora Neuroscience's Cirrus Resting State fMRI Software are not publicly available in the provided information. Physicians interested in pricing models, subscription fees, or hardware investments would need to contact Sora Neuroscience directly for a quote and licensing options.
Cirrus was developed and clinically investigated at Washington University in St. Louis, a leader in resting-state brain activity research. Clinical validation studies demonstrate its comparability to task-activated maps and its substantial equivalence to a predicate device, showing strong spatial correlation with published literature for motor, language, and vision networks.
Cirrus utilizes resting-state fMRI, which does not require patient participation in tasks, making it highly beneficial for populations unable to cooperate with traditional task-based fMRI. This includes children, cognitively impaired patients, or those requiring sedation or anesthesia, thereby broadening access to fMRI mapping.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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