BrainSpec AI Software Receives FDA Clearance for Noninvasive Brain Chemistry Assessment

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12/06/2023

The Food and Drug Administration (FDA) has awarded clearance to the artificial intelligence (AI) software platform BrainSpec Core (BrainSpec, Boston, MA) as a tool for measuring brain chemistry noninvasively based on magnetic resonance spectroscopy (MRS) data. BrainSpec Core is designed to assist clinicians in the evaluation and diagnosis of neurologic conditions including Alzheimer disease (AD), multiple sclerosis (MS), epilepsy, brain tumors, and traumatic brain injury (TBI). This is the first FDA clearance for a software that uses a brain chemistry reference database. BrainSpec Core previously received FDA breakthrough device designation as a tool for estimating isocitrate dehydrogenase (IDH) status in people with glioma.

MRS is performed with the same equipment as MRI, using magnetic fields and radio waves to generate spectra to determine the chemical composition of the brain as well as to identify changes in the metabolic pathways of brain tissues. The BrainSpec Core platform detects differences in relative metabolite levels across the brain and feeds this data into AI models to assist with assessment.

"There are several key advantages of this AI solution that have important clinical relevance," said Raymond Y. Huang, MD, PhD, Division Chief of Neuroradiology at Brigham and Women's Hospital. "First, it provides quantitative neurometabolite measurements that can be used to aid in monitoring the changes in brain tumors that are undergoing therapy. The second strength is that it automates the delivery of the MR spectroscopy results, reducing turn-around time from days to minutes which is critical for the clinical care of patients. Finally, ability to measure 2-hydroxyglutarate and other brain metabolites provides a direct and non-invasive marker of low-grade gliomas that could lead to a more accurate classification of individual tumors benefitting decision making."

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