CorTechs Labs Receives 510(k) Clearance from US FDA for NeuroQuant for Quantitative Brain Image Analysis

CorTechs Labs, the leading medical software innovator providing solutions for quantitative brain volume analysis, is pleased to announce that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for NeuroQuant®.

Previously cleared for automatic labeling and volumetric quantification of segmentable brain structures from MRIs, this latest clearance unveils updated and advanced NeuroQuant features for the US market.

“This latest U.S. FDA 510(k) clearance is a continued testament to our commitment to quality and performance of NeuroQuant,” said Guri Stark, CorTechs Labs’ CEO. “CorTechs Labs’ outstanding engineering team has developed a robust and sophisticated quantitative image analysis software above what is currently available in the market. We are excited to provide the next level of quantitative brain volume analysis software to assist physicians and researchers in their assessment of neurological conditions via MR imaging.”


  • Fast, accurate and automated quantitative MR image analysis
  • Proven and consistent brain structure segmentation and volume measurement
  • Dynamic Atlas™ provides personalized brain segmentation driven by advanced precision
  • Normative reference data, available for ages 3 years to 100, compares patient brain volumes to healthy cohorts based on age and gender
  • Volumetric reports provide physicians with supplemental information for the assessment of neurological conditions
  • LesionQuant module provides quantitative analysis of FLAIR lesion volumes and brain structures
  • Compatible with Siemens, GE, Philips, and Toshiba (1.5T and 3.0T) and Hitachi (1.2T, 1.5T and 3.0T)
  • Longitudinal tracking to evaluate brain structure volumes overtime

About CorTechs Labs

CorTechs Labs develops and markets breakthrough medical device software solutions capable of automatically segmenting and quantifying brain structures, making quantitative analysis of the human brain a routine part of clinical practice. CorTechs Labs’ cutting-edge brain imaging analysis provides neurologists, radiologists, and clinical researchers worldwide with a convenient and cost-effective means to quantify subcortical structures to help assess a variety of neurological conditions, such as Alzheimer’s disease, epilepsy, multiple sclerosis, brain trauma and brain…

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