Omniscient has secured the US Food and Drug Administration (FDA) approval for its new functional brain mapping software, Quicktome Functional Connectome (FC).
Quicktome FC, a major upgrade to the company’s existing Quicktome platform, can map the functional connectivity patterns of a patient’s brain in a single MRI scan.
The Quicktome platform, which is used in neurosurgical applications, has been extended to provide connectomic insights for a wide range of neurological disciplines.
The upgrade also includes Connectomics Discovery Mode, which offers access to powerful experimental connectomic analysis tools in a research setting.
Quicktome FC facilitates the use of functional MRI data for connectomic outlier detection, to enable the creation of neurological biomarkers for various disorders, said the company.
Omniscient chief medical officer Michael Sughrue said: “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 has integrated resting-state functional MRI (rs-fMRI) technology into its Quicktome platform to provide a safe, non-invasive imaging option for neurological disorders.
The rs-fMRI scans are safe, painless, and non-invasive, and are used to measure the brain network connections while the patient is at rest.
Quicktome FC is the first neurological planning and visualisation tool to leverage rs-fMRI.
The FDA approval allows clinicians to analyse the brain network activity crucial for functions like movement, speech, and vision, without needing specialised technicians or patient tests.
Omniscient intends to commercialise the functional brain-mapping technology in a significant software release this year.
Omniscient CEO Stephen Scheeler said: “Omniscient’s mission is to improve the lives of billions through using AI to decode the human brain – a field known as connectomics.
“We are entering an exciting new era where we can provide clinicians with the precise, personalised data to understand an individual’s brain function beyond merely generalised symptoms and chemistry.
“This technology offers medicine a new horizon of neurological understanding and precision treatment.”
