Receiving CE Marking is a major step in reaching the European market. By successfully completing this process, CorTechs Labs has demonstrated that NeuroQuant complies with applicable European health, safety, performance and environmental protection.
San Diego, CA (PRWEB) July 09, 2014
CorTechs Labs, Inc. is pleased to announce that it has received CE Marking allowing the distribution in the European Economic Area (EEA) of their software product NeuroQuant, the leading volumetric brain imaging device. Already FDA Cleared and used by many reputable clinics and hospitals, NeuroQuant provides cutting-edge data analysis and detection of atrophy in the human brain with fully automated MRI post-processing capabilities. This product provides neurologists, radiologists, and clinical researchers with a cost-effective and convenient way to accurately quantify the volumes of specific brain structures in order to more efficiently give insight on conditions such as Alzheimer’s disease traumatic brain injury, multiple sclerosis and epilepsy.
Now, with the availability of CE Marking, European customers can start using NeuroQuant in clinical practice. “Receiving CE Marking is a major step in reaching the European market. By successfully completing this process, CorTechs Labs has demonstrated that NeuroQuant complies with applicable European health, safety, performance and environmental protection legislative requirements and it can now offer NeuroQuant for clinical and commercial use to hospitals, physicians and research institutions not only in Europe, but also in many other countries where the CE Mark allows commercialization,” commented Kora Marinkovic, Director of Regulatory Affairs, CorTechs Labs.
In addition to receiving the CE Mark, CorTechs has also received ISO 13485 Certification for their Quality Management System, meeting the quality system requirements in Europe, Canada, Japan, Australia and other countries. Compliance with Medical Device Standard ISO 13485 also demonstrates to CorTechs’ customers and partners its commitment to quality.
“Our goal is to make NeuroQuant the global gold-standard for measurement of brain volumes and brain atrophy. We are excited to introduce our innovative brain imaging solution to the European market and expand access to reliable quantitative measurements of brain atrophy from MRI images,” said Guri Stark, CEO of CorTechs Labs. “NeuroQuant can now bear the CE Mark, which testifies to our commitment to quality, safety and performance.”
About CorTechs Labs, Inc.
CorTechs Labs develops and markets cutting-edge brain imaging solutions used by neurologists and radiologists in hundreds of clinics and research centers around the world. CorTechs' flagship product, NeuroQuant®, is a breakthrough, 510(k)-cleared and CE-Marked software medical device that makes quantitative analysis of MRI images of the human brain a routine part of clinical practice. As the first FDA-cleared medical device capable of automatically detecting and quantifying atrophy in the human brain, NeuroQuant® brings sophisticated, accurate, and fully automated MRI post-processing capabilities to the physician's desktop or mobile device. This provides neurologists, radiologists, and clinical researchers with a convenient and cost-effective means to quantify atrophy of brain structures to help in the assessment of a variety of neurodegenerative brain disorders, including conditions such as Alzheimer's disease, epilepsy, multiple sclerosis and traumatic brain injury. For more information about NeuroQuant and CorTechs Labs, please visit, http://www.cortechslabs.com.