New AI-based brain mapping tool receives FDA clearance for use in neurosurgery

New AI-based brain mapping tool receives FDA clearance for use in neurosurgery

A new AI-based technology that uses the brain to quickly locate sensitive areas that control speech, vision, movement and other critical functions has received approval from the Food and Drug Administration (FDA) so it can be marketed to hospitals to improve the precision of neurosurgery procedures. The technology was developed by researchers and clinicians at Washington University School of Medicine in St. Louis to more accurately guide neurosurgeons in performing fine brain surgeries to remove tumors or treat epilepsy.

Cirrus Rasting State FMRI software is being launched by Sora Neuroscience, Inc., a Washu startup that licenses the university's technology. The technology is based on decades of Washu medicine leadership in neuroscience and functional brain imaging. The development was funded by the National Institutes of Health (NIH) with support from private investors.

“This will be a sea change for clinical imaging and brain mapping,” said Eric C. Leuthardt, MD, the Shi H. Huang Professor of Neurological Surgery, who developed the technology at Washu Medicine and co-founded SORA Neuroscience. “Now clinicians have access to a broader and more accessible way to study brain function that can quickly provide insights into neurosurgery and brain disease applications that benefit patients.”

The development of Cirrus software underscores the important role that academic entrepreneurs and startup companies play in translating discoveries into real-world solutions that improve people's lives, said Doug E. Frantz, vice chancellor for innovation and commercialization at Washu.

Transforming years of scientific advances into a tool that surgeons can use in the operating room is only possible through partnerships with commercial companies like Sora Neuroscience and Washu Medicine faculty, who helped launch the company. This is a clear example of how entrepreneurship drives the translation of groundbreaking research from the laboratory to patient care. “

Doug E. Frantz, PhD, Vice Chancellor for Innovation and Commercialization, Washu

Cirrus' FMRI resting state software can identify distinct networks of brain activity that regulate important activities such as speech, vision and movement and create maps of their locations. Typically, such maps require specialized staff and up to an hour in a scanner to map such networks. The algorithms in Cirrus software, based on artificial intelligence technology, can analyze patterns of associated activity in a resting brain that are known to correspond to specific brain functions. They can complete their mapping of multiple brain networks from just 12 minutes of functional magnetic resonance imaging (FMRI), which tracks changes in the brain's blood flow to identify areas of neurological activity.

The scans for the Cirrus software are performed while a person is at rest in the MRI machine, rather than performing a task such as speaking or moving fingers and toes to activate specific brain networks. Leuthardt explained that task-based FMRI is only able to produce usable maps for surgeons about two-thirds of the time, typically due to patient movement or inability to participate in the task. In contrast, 87% of Cirrus' scans can be reliably incorporated into a surgeon's operational plan.

Task-based FMRI is also limited to those who can perform those tasks and follow instructions. For this reason, Cirrus Rasting State's FMRI software process will make fMRI mapping available to a much larger group of patients, said Joshua Shimony, MD, professor of radiology at the Washu Medicine Mallinckrodt Institute of Radiology, a co-investigator with Leuthardt, who teaches the technique.

“The resting state FMRI can be performed on patients who have difficulty with task-based FMRI, such as:

Leuthardt said that while the technology was initially developed in his lab, the underlying data comes from decades of Washu Medicine-led FMRI imaging research by Raststaat. Carl Hacker, MD, PhD, who recently completed his neurosurgery training at Washu, developed the AI-based algorithms that power the Cirrus program while he was a graduate student in Leuthardt's lab. Physicians and scientists have worked together for years to develop and promote imaging analytical capabilities for preoperative brain mapping and to conduct effectiveness studies.

Washu's Office of Technology Management filed the first patents more than a decade ago and licensed the technology to Sora Neuroscience in 2021. The company was founded in 2020 by Leuthardt along with Hacker and Washu Medicine Professor of Radiology Daniel Marcus, PhD, and Assistant Professor of Radiology Mikhail Milchenko, PhD.

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