CorTechs Labs Inc. announces NeuroQuant® approval from The National Health Surveillance Agency (ANVISA) to be sold commercially in Brazil
(SAN DIEGO) October 10, 2019 – NeuroQuant officially launched in Brazil after gaining regulatory clearance allowing for the commercial sale of NeuroQuant for clinical use across Brazil.
“This clearance will pave the way for continued growth and expansion within South America,” said Chris Airriess, chief executive officer of CorTechs Labs. “It is a big milestone for the company’s global reach, and we look forward to continuing to help physicians around the world have access to cutting-edge technology.”
NeuroQuant uses machine learning to provide automatic image segmentation and quantification from magnetic resonance imaging (MRI), revealing the presence of various biomarkers. Values are compared to a unique normative database of patients the same age and sex to aid physicians in making clinical decisions regarding neurodegenerative diseases.
“The arrival of NeuroQuant in Brazil marks an important step in the diagnosis and treatment of Alzheimer’s disease, multiple sclerosis and other neurodegenerative conditions,” said NeuroQuant customer, Dr. Pablo Coimbra of Uniclinic Diagnóstico por Imagem. “I expect NeuroQuant to become standard technology across all Brazilian imaging centers, which will transform neurodegenerative diagnoses and patient care.”
NeuroQuant is a companion evaluation tool for diseases such as Alzheimer’s disease, epilepsy, traumatic brain injury and multiple sclerosis. LesionQuant, a module of NeuroQuant and primarily used in the evaluation of multiple sclerosis, is encompassed in the new NeuroQuant approval. LesionQuant quantifies, counts, and segments lesions, as well as provides a lesion burden calculation as compared to healthy white matter.
“Adding NeuroQuant to our clinics has led to earlier diagnosis of neurodegenerative diseases with increased diagnostic confidence,” added Dr. Renato Hoffman Nunes of Diagnosticos da America S.A., another NeuroQuant customer in Brazil.
The clearance marks the fifth approval NeuroQuant received since its U.S. Food and Drug Administration (FDA) 510(k) clearance in 2006. NeuroQuant is additionally CE marked for distribution in Europe and approved for use in Canada, South Korea, Australia and now Brazil. More than 500,000 NeuroQuant reports have been processed by over 800 international institutions in 35 countries. CorTechs Labs plans to expand further into the Brazilian market in 2020.
CorTechs Labs’ flagship product, NeuroQuant, is the first FDA 510(k) cleared, CE marked and Health Canada, Australia, Korea, Brazil approved medical device software, providing physicians with fast, accurate and fully automated quantitative 3D T1 MRI post-processing image analysis. NeuroQuant is used by physicians worldwide in patients ranging from three to 100 years of age as a supplemental tool to measure brain structure volumes and confidently assess the presence of neurodegeneration of brain structures.
The LesionQuant module of NeuroQuant can assist physicians in their clinical evaluation process, clinical treatment planning and monitoring of disease progression by combining T2 FLAIR with 3D T1 scans for quantitative lesion analysis. It automatically visualizes lesions and lesion volume changes and provides longitudinal changes in brain structure volumes.
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 development abnormalities. Please visit www.cortechslabs.com for further information and follow us on Twitter, LinkedIn and Facebook.