FDA OKs WashU-Developed AI Brain Mapping Software

The U.S. Food and Drug Administration (FDA) has authorized a new artificial intelligence (AI)-based tool that quickly maps the brain to locate sensitive areas that control speech, vision, movement, and other functions. It will be marketed to hospitals with the aim of enhancing the precision of neurosurgeries.

The technology was developed by researchers and clinicians at Washington University School of Medicine in St. Louis to more precisely guide neurosurgeons in performing delicate brain surgeries to remove tumors or treat epilepsy.

The Cirrus Resting State fMRI software is being commercialized by Sora Neuroscience, a WashU startup that licensed the tech from the university. It’s built on decades of WashU leadership in neuroscience and functional brain imaging.

The software can identify distinct networks of brain activity that govern language, vision, and movement and create maps of their locations. Its algorithms can analyze patterns of linked activity in a resting brain that are known to relate to specific brain function. Mapping of multiple brain networks can be completed from 12 minutes of functional magnetic resonance imaging (fMRI), which tracks changes in the brain’s blood flow to identify areas of neurological activity.

“This is going to 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 look at brain function that can quickly provide insights across neurosurgery applications and for brain diseases, which will benefit patients.”

Scans for the Cirrus software are done while a person is at rest in the MRI. Dr. Leuthardt explained task-based fMRI can only create usable maps for surgeons about two-thirds of the time, usually because the patient moves or cannot participate in the task. 87% of Cirrus’ scans can be reliably incorporated into an operating plan.

Cirrus Resting State fMRI software procedure will make fMRI mapping available to a much larger group of patients, said Joshua Shimony, MD, Ph.D., a professor of radiology at WashU Medicine Mallinckrodt Institute of Radiology, who was a co-investigator with Leuthardt on the studies underlying the technology and is also a scientific advisor to Sora Neuroscience.

“Resting state fMRI can be done on patients who have difficulty with task-based fMRIs, such as children, patients who are confused or who need sedation or anesthesia, or those who are hard of hearing or don’t speak English,” he said.