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Quantib gets FDA and CE mark approval for Alzheimer's and MS diagnostic tool for MR

Press releases may be edited for formatting or style | August 11, 2016 MRI
ROTTERDAM, The Netherlands, August 8, 2016 – Medical image quantification software provider Quantib B.V. today announced it has received approval from U.S. and European regulators to market its first product, Quantib Brain 1.1 in their jurisdictions. The company received European Union CE marking and clearance from the U.S. Food and Drug Administration for its advanced analytical software. Quantib Brain 1.1 automatically extracts biomarkers from brain MRI scans. Such neurobiomarkers are strongly correlated with the onset and development of neurodegenerative and inflammatory diseases such as Alzheimer's and multiple sclerosis.

“We are extremely pleased that our first product, Quantib Brain, was certified in two major markets in such a timely fashion. Now patients can begin to benefit from Quantib Brain’s ability to help radiologists and neurologists assess brain MRI scans faster and with a higher degree of objectivity and reliability,” said Quantib CEO, Rudolf Scholte. “Previously this type of advanced neurological analytics was available only in research labs. Now clinicians can use Quantib Brain in daily practice―this was a primary objective of our work and represents a major stride in addressing neurodegenerative and neuroinflammatory diseases.”

Quantib Brain is the first and only third-party software that is fully integrated with the GE Advantage Workstation workflow. The GE Advantage Workstation is one of the world’s most widely-used 3D visualization and analysis solutions.

According to Aad van der Lugt, M.D., Ph.D., Professor of Neuroradiology and Head-Neck Radiology at Erasmus MC, Quantib Brain’s robust quantitative imaging biomarkers can enhance radiologists’ objectivity in brain MRI evaluations and enable the detection of subtle abnormalities and changes while ensuring their full control over the final radiological report.

About Quantib B.V.
Quantib develops certified medical image quantification software and biomarker services for radiologists, neurologists, and researchers in conformance with ISO-13485:2012. Its MRI and CT image analysis software enables physicians and researchers to extract imaging biomarkers in five body sites (i.e., abdominal, cardiovascular, lung, musculoskeletal, neuro(vascular) for faster and more accurate and cost-effective diagnoses. Quantib’s clinically-validated algorithms were tested on over 10,000 scans in the Rotterdam Scan Study, a research project of the Departments of Epidemiology and Radiology, Erasmus MC. For more information visit www.quantib.com.

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