BrainSpec, the comprehensive software platform enabling virtual biopsies of the brain, has been awarded clearance by the FDA to begin using its Magnetic Resonance Spectroscopy (MRS) platform to provide non-invasive measurement of brain chemistry to support the diagnostic process in the most common brain-related illnesses, including Alzheimer’s disease, multiple sclerosis, epilepsy, brain tumors, and more. This marks the first-time software using a reference database of brain chemistry has been included in an FDA clearance, according to the company.

By using non-invasive imaging, BrainSpec Core measures concentrations of chemicals in the brain in order to create a virtual biopsy using standard MRI scanners. Unlike MRI, which provides anatomical images, MRS delves into the chemical composition of tissues, opening up new avenues for precise diagnosis and treatment. While standard MRI produces images of the brain by visualizing fat and water distributions, MRS detects metabolites which are present at much lower concentrations. 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. The software can be used across GE, Siemens and Philips 3T MRI scanners making it accessible to any medical facility via cloud-based systems.

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“We are thrilled to be given this full clearance by the FDA. It signals a new era of software enhancements that will not only complement but also speed up the complicated and lengthy process of diagnosis. Our aim is not to replace the critical role of physicians but to augment their expertise with invaluable information previously unavailable. We believe that by equipping healthcare professionals with cutting-edge tools, we can empower them to make more informed and precise treatment decisions, ultimately leading to improved patient care.” says Alex Zimmerman, CEO and co-founder, BrainSpec.

Adding MRS to the diagnostic process has been shown to save as much as $98,000 per patient in healthcare costs compared to current standard of care alone over a five-year time horizon, the company says.

“There are several key advantages of this AI solution that have important clinical relevance,” says Raymond Y. Huang, MD, PhD, Division Chief, Neuroradiology, 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.”

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.

“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,” says David A. Reardon, MD, Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute. “There has been a high unmet medical need for reliable and quantitative neuroimaging methods for the management of brain tumor patients.”