FDA clears platform for non-invasive brain chemistry measurement

The FDA has cleared the use of a magnetic resonance spectroscopy platform to provide non-invasive measurement of brain chemistry and support diagnostic processes for a range of brain-related illnesses.

According to a release from BrainSpec, the novel software platform will allow for virtual biopsies of the brain to aid in diagnosis of conditions including Alzheimer’s disease, multiple sclerosis, epilepsy and brain tumors. Clearance by the FDA marks the first time software that utilizes a reference database of brain chemistry has been approved, the company said.

“Our aim is not to replace the critical role of physicians but to augment their expertise with invaluable information previously unavailable,” BrainSpec CEO and co-founder Alex Zimmerman said in the release. “We believe that by equipping health care professionals with cutting-edge tools, we can empower them to make more informed and precise treatment decisions, ultimately leading to improved patient care."

BrainSpec Core measures concentrations of chemicals in the brain to create a virtual biopsy using standard MRI scanners, but in a non-invasive fashion.

Magnetic resonance spectroscopy analyzes brain chemistry to detect metabolites which are present at much lower concentrations, contrasting with standard MRI, which produces images of the brain by visualizing fat and water distributions.

BrainSpec additionally utilizes advanced signal processing methods to measure relative metabolite levels across the brain, which, over time, produces multidimensional data that can be distributed into artificial intelligence models. The software can be used across General Electric, Siemens and Philips 3T MRI scanners, for easy access within medical facilities via cloud-based systems, per the release.

“The ability to measure relative 2-hydroxyglutarate levels leads to a more accurate classification of individual tumors benefiting treatment decision making which is in the best interest of patients,” David A. Reardon, MD, clinical director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, said in the release.