Omniscient gets FDA clearance for new MRI-based functional BAT

Omniscient, the world leader in using AI to decode the human brain, today announced FDA clearance of its new functional brain mapping software release, ‘Quicktome FC (Functional Connectome)’, which can reveal in a single scan the unique connectivity patterns of an individual’s brain. Through this major platform upgrade to their award-winning Quicktome platform, which is currently used in neurosurgical applications, the company is expanding the software’s use to empower connectomic insights for a wider array of neurological disciplines.

In addition to expanding functionality for clinical use, this upgrade introduces ‘Connectomics Discovery Mode’ to users. This module offers access to powerful experimental connectomic analysis tools in a research setting. This includes using functional MRI data for connectomic outlier detection, guiding the creation of neurological biomarkers for various disorders.

Integrating resting-state functional MRI (rs-fMRI) technology into Omniscient’s Quicktome platform provides patients and their physicians a safe, non-invasive imaging option to guide treatment strategies for neurological disorders. It is the first neurological planning and visualization tool using rs-fMRI to become commercially available to clinicians.

This coincides with increasing evidence which shows many neurological and mental disorders stem from brain network miscommunications and irregularities in the brain’s electrical functions. Resting-state fMRI scans, which are safe, painless, and non-invasive, measure these connections while the patient is at rest. The recent clearance allows clinicians to analyze network activity crucial for functions like movement, speech, and vision, all without specialized technicians or task-specific patient tests. The technology is slated for commercial availability in a significant software release expected in 2023.

Dr Michael Sughrue, Chief Medical Officer of Omniscient, celebrated the clearance, “Today’s clearance is a landmark moment, not only for Omniscient but for the entire field of clinical neuroscience. As a clinician, I’ve faced the frustration of not being able to comprehensively care for patients due to a lack of patient-specific, precision brain data. This clearance will help transform how brains are assessed in routine patient care.”

“Omniscient’s mission is to improve the lives of billions through using AI to decode the human brain – a field known as connectomics” said Omniscient CEO Stephen Scheeler. “We are entering an exciting new era where we can provide clinicians with the precise, personalized data to understand an individual’s brain function beyond merely generalized symptoms and chemistry. This technology offers medicine a new horizon of neurological understanding and precision treatment.”
MB Bureau