Quantib announces U.S. FDA clearance

ROTTERDAM, THE NETHERLANDS, January 7, 2019 - Quantib, market leader in AI tools for radiologists, announces that the U.S. Food and Drug Administration (FDA) has cleared their radiology software product Quantib™ ND for distribution in the USA.

Quantib™ Neurodegenerative (ND) supports the radiologist with the reading of MRI brain scans. The software measures brain atrophy (shrinkage) and detects white matter hyperintensities (WMHs), which are changes in the brain related to, for example, aging, dementia and multiple sclerosis (MS).

“This is an important achievement’’, said Arthur Post Uiterweer, CEO of Quantib. “We are very proud to offer physicians an extensive software package for quantitative measurements of neurological changes that can be related to dementia and MS”. With this clearance, Quantib continues to show its strength in developing products and bringing them successfully through the clearance process.

Quantib™ ND, software for neurodegeneration tracking

The software includes fully automatic segmentation of lobes and hippocampus to objectively assess atrophy development. Additionally, it comprises white matter hyperintensity segmentation for easy monitoring neurological changes occurring in for example dementia and MS patients. Reference centile curves, derived from the population-based Rotterdam Scan Study, provide an intuitive tool to compare the patient’s brain volume to the average of an unbiased population.

Quantib™ ND's follow-up feature tracks neurodegeneration over time. Accurate alignment of images at subsequent time points enable accurate detection and staging of atrophy, combined with WMH tracking. The software visualizes new and previously identified lesions using color-coded overlays. The editing feature grants the radiologist full control of final results before sending them to the PACS.

Quantib™ ND is installed on the premises of the hospital where patient scans are processed behind the hospital firewall, offering the most secure option to protect patient data.

About Quantib B.V.

Quantib, a leader in AI software for radiologists, strives for faster and more accurate diagnoses, supporting adequate and timely patient care. Using advanced machine learning techniques, Quantib’s products can detect changes in tissue sooner than would be possible with the naked eye. Quantib has multiple machine-learning products cleared by FDA and CE. Released products are focused on quantification and diagnosis of neurodegenerative disease. Additionally, Quantib is backed by Erasmus MC Rotterdam and UMC Utrecht ensuring access to large scale structured imaging data. New product development focuses on oncology and stroke related products.