BrainSpec Receives Full FDA Clearance to Begin Using AI-Backed Solution for Non-Invasive Brain Chemistry Measurement
Summary
BrainSpec uses advanced signal processing methods to measure relative metabolite levels across the brain and over time, generating rich multidimensional data that can be fed into powerful AI models. "There are several key advantages of this AI solution that have important clinical relevance," said Raymond Y. Huang, MD, PhD, Division Chief, Neuroradiology, Brigham and Womens Hospital. 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." "The ability to measure relative 2-hydroxyglutarate levels leads to a more accurate classification of individual tumors benefitting treatment decision making which is in the best interest of patients," said David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute. -David A. Reardon, M.D., In June 2022, BrainSpec received FDA designation as a Breakthrough Device for estimating isocitrate dehydrogenase (IDH) status in glioma patients, for whom biopsies are inadvisable.