Sam Brusco, Associate Editor11.27.23
BrainSpec, a software platform that enables virtual brain biopsies, was awarded U.S. Food and Drug Administration (FDA) clearance to use its Magnetic Resonance Spectroscopy (MRS) platform for non-invasive measurement of brain chemistry to support the diagnostic process in Alzheimer's disease, multiple sclerosis, epilepsy, brain tumors, and more.
BrainSpec Core uses non-invasive imaging to measure concentrations of brain chemicals to create a virtual biopsy using standard MRI scanners. MRS delves into the chemical composition of tissues and detects metabolites that are present at much lower concentrations. Its advanced signal processing measures relative metabolite levels across the brain, and can generate over time rick multidimensional data that can be fed into artificial intelligence (AI) models.
The software can be used in GE HealthCare, Siemens Healthineers, and Philips 3T MRI scanners. The company said using MRS for diagnostics can save as much as $98,000 per patient in healthcare costs compared to the current standard of care alone over a five-year period.
"We are thrilled to be given this full clearance by the FDA,” BrainSpec co-founder and CEO Alex Zimmerman told the press. “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."
"There are several key advantages of this AI solution that have important clinical relevance," added Raymond Y. Huang, MD, Ph.D., 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 gained FDA breakthrough status to estimate isocitrate dehydrogenase (IDH) status in glioma patients, for whom biopsies are inadvisable.
BrainSpec Core uses non-invasive imaging to measure concentrations of brain chemicals to create a virtual biopsy using standard MRI scanners. MRS delves into the chemical composition of tissues and detects metabolites that are present at much lower concentrations. Its advanced signal processing measures relative metabolite levels across the brain, and can generate over time rick multidimensional data that can be fed into artificial intelligence (AI) models.
The software can be used in GE HealthCare, Siemens Healthineers, and Philips 3T MRI scanners. The company said using MRS for diagnostics can save as much as $98,000 per patient in healthcare costs compared to the current standard of care alone over a five-year period.
"We are thrilled to be given this full clearance by the FDA,” BrainSpec co-founder and CEO Alex Zimmerman told the press. “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."
"There are several key advantages of this AI solution that have important clinical relevance," added Raymond Y. Huang, MD, Ph.D., 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 gained FDA breakthrough status to estimate isocitrate dehydrogenase (IDH) status in glioma patients, for whom biopsies are inadvisable.