Qynapse Secures FDA Clearance for Neurodegenerative Disease Imaging Software

February 3, 2020

Imaging software allows automated quantification of markers for early diagnosis and clinical monitoring.

France-based medical technology company Qynapse announced Monday it has secured 510(k) clearance from the U.S. Food and Drug Administration for its QyScore® imaging software.

QyScore® is designed to analyze brain MRI markers that intervene early with neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, or multiple sclerosis. It quantifies changes over time in affected regions of the brain, and, according to company information, it can reduce image analysis time and cost by approximately 80 percent.

According to Bruno Dubois, professor of neurology at Sorbonne University in Paris and Director of the Memory and Alzheimer’s Disease Institute at Pitié Salpêtrière Hosptial, who has worked with the software, QyScore® offers several benefits.

“QyScore® makes a difference for the diagnosis of dementias at an early stage of the disease when it remains a challenge,” he said in a company press release. “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.”

By combining an advanced user interface with automatically generated patient reports, the software presents results alongside a comparison with a healthy subject database. Doing so can potentially help neurologists and radiologists in clinical decision-making. Through compatibility with clinical routine work, the software can support differential diagnosis and clinical progression measure, and it can also be used in clinical trials to assess drug safety and efficacy, the company reported.

With FDA clearance, said Olivier Courrèges, Qynapse chief executive officer, the company plans to increase collaboration with U.S. neurology experts and healthcare providers to improve patient care.

QyScore® has been available in Europe since September 2017.