QyScore, Imaging Software that Analyzes MRI Markers of Brain Disease, Earns FDA Clearance

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for QyScore, a cloud-based imaging software for the automated quantification of key magnetic resonance imaging (MRI) markers of central nervous system (CNS) disease.

MRI is an important tool for diagnosing multiple sclerosis and other CNS disorders. By means of strong magnetic fields, magnetic field gradients, and radio waves, MRI scanners generate images of the organs in the body. Doctors order an MRI of the brain or spine and look for lesions, which show up as white or dark spots, depending on the type of scan.

QyScore, which received CE mark approval in Europe in September 2017, automatically analyzes a patient’s MRI images, quantifies relevant markers of disease, compares the results with a large dataset of healthy people (controls), and quantifies changes longitudinally over time.

The imaging software by medical technology company Qynapse standardizes image analysis, eliminates inter- and intra-rater variability in image reading (eliminates subjectivity in the interpretation of the MRI by different doctors or the same doctor on different occasions). It also reduces the time and cost of image analysis, and provides reliable results in a few minutes, either through an intuitive user interface or a clinical report.

“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,” Bruno Dubois, said in a press release. Dubois is professor of neurology at Sorbonne University, and director of the Memory and Alzheimer’s Disease Institute (IM2A) at Pitié Salpêtrière Hospital, in Paris, France,

According to Qynapse, this advanced imaging software will help in the early diagnosis of neurodegenerative diseases, including multiple sclerosis, and Alzheimer’s and Parkinson’s diseases. It also will allow clinical monitoring of patients to assess the effectiveness of medicines and their adverse side effects more precisely and objectively.

QyScore can be fully integrated into routine hospital workflows through leading radiological information systems, and can be operated with commonly used MRI scans.

“FDA clearance is a major milestone to expand the commercialization of the software within the U.S.,” said Olivier Courrèges, CEO of Qynapse. “Qynapse will accelerate collaboration with experts and healthcare providers in the U.S. to pursue its journey for better patient care in neurology.”