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FDA Clears Magnetic Resonance Spectroscopy Platform for Non-Invasive Assessment of Brain Chemistry

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BrainSpec Core reportedly offers enhanced sensitivity for low-grade gliomas and may facilitate the diagnosis of conditions including Alzheimer’s disease, multiple sclerosis, and epilepsy.

The Food and Drug Administration (FDA) has granted 510(k) clearance for BrainSpec Core™, a magnetic resonance spectroscopy (MRS) software that utilizes a reference base of brain chemistry to help detect a variety of common brain-related conditions ranging from epilepsy and brain tumors to Alzheimer’s disease.

Employing advanced signal processing methods, BrainSpec Core offers insight into the chemical composition of brain tissue and measurement of metabolite levels in the brain, according to BrainSpec, the developer of the software.

The company pointed out that BrainSpec Core has demonstrated an 85 percent sensitivity rate and a 90 percent specificity rate for the oncometabolite 2-hydroxyglutarate, which is present in low-grade gliomas.

“(The) 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,” noted Raymond Y. Huang, M.D., Ph.D, the division chief of neuroradiology at Brigham and Women's Hospital.

BrainSpec added that BrainSpec Core can be utilized with 3T MRI scanners from GE HealthCare, Siemens Healthineers and Philips.

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