FDA Clears Magnetic Resonance Spectroscopy Platform for Non-Invasive Assessment of Brain Chemistry
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.
Can Contrast-Enhanced Mammography be a Viable Screening Alternative to Breast MRI?
June 17th 2025While the addition of contrast-enhanced mammography (CEM) to digital breast tomosynthesis (DBT) led to over a 13 percent increase in false positive cases, researchers also noted over double the cancer yield per 1,000 women in comparison to DBT alone.
How to Successfully Launch a CCTA Program at Your Hospital or Practice
June 11th 2025Emphasizing increasing recognition of the capability of coronary computed tomography angiography (CCTA) for the evaluation of acute and stable chest pain, this author defuses common misperceptions and reviews key considerations for implementation of a CCTA program.
Study: AI-Generated ADC Maps from MRI More Than Double Specificity in Prostate Cancer Detection
June 5th 2025Emerging research showed that AI-generated ADC mapping from MRI led to significant increases in accuracy, PPV and specificity in comparison to conventional ADC mapping while achieving a 93 percent sensitivity for PCa.
