The Food and Drug Administration (FDA) gave a 510(k) clearance for analysis software (QyScore, Qynapse, Paris, France). The software provides robust and precise analyses of brain MRI markers found early in the process of neurodegenerative diseases such as Alzheimer disease (AD), Parkinson disease (PD) or multiple sclerosis (MS).
The software combines an advanced user interface with individual reports that are generated automatically in minutes. The results are presented in comparison with a database of information from healthy individuals, supporting neurologists and radiologists in their clinical decision-making. The software is compatible with the routine clinical workflow to support differential diagnosis and measures of clinical progression. It is also being used in clinical trials for monitoring of drug efficacy and safety.
The software demonstrates its value by quantifying longitudinal changes of regions of interest in the brain, eliminating the interrater and intrarater variability in images reading, and reducing the time and cost of image analysis. Commercialization of the software started in Europe following the certification mark approval in September 2017.
According to Pr. Bruno Dubois, professor of Neurology at Sorbonne University, and director of the Memory and Alzheimer Disease Institute (IM2A) at Pitié Salpêtrière Hospital in Paris, "QyScore makes a difference for the diagnosis of dementias at an early stage of the disease when it remains a challenge. The automatic quantification of markers such as brain atrophy, white matter hyperintensities, and more provides highly valuable help to support a timely diagnosis and an efficient monitoring of disease progression."
"FDA clearance is a major milestone to expand the commercialization of the software within the US," said Olivier Courrèges, CEO of Qynapse. "Qynapse will accelerate collaboration with experts and healthcare providers in the US to pursue its journey for better patient care in neurology."
Stephanie Kazi, BS; Caleb Heiberger, BS; and Divyajot Sandhu, MD
Zehra Farzal, MD; Guillaume Lamotte MD, MSc; Elizabeth Mundel, MD; Laxman B. Bahroo, DO; and Fernando L. Pagan, MD