Imaging Analysis Software QyScore Receives FDA Clearance

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Qynapse‘s QyScore, a software that aids in analyzing brain scans taken by magnetic resonance imaging (MRI).

The software, which is compatible with routine imaging workflows, includes an advanced user interface and automatically-generated patient reports. Results are presented in comparison to data on people without known brain disease, giving neurologists and radiologists support in making clinical interpretations and decisions for treatment in a number of conditions, including Parkinson’s disease, multiple sclerosis, and Alzheimer’s disease.

In addition to aiding in diagnostics and monitoring disease progression, the software has been employed in clinical trials to help measure responses to treatment and safety profiles for investigational therapies.

Doing this kind of imaging analysis with a computer program, rather than relying on humans to interpret images, helps cut down on costs and time associated with the analyses. It also reduces variability in interpreting results. This includes both person-to-person variability and variability that can occur for the same person reading images at different times, since the computer is not subject to the same variances that can affect human scorers.

“QyScore makes a difference for the diagnosis of dementias at an early stage of the disease when it remains a challenge,” Bruno Dubois, PhD, said in a press release. Dubois is a professor at Sorbonne University and director of the Memory and Alzheimer’s Disease Institute at Pitié Salpêtrière Hospital in Paris. “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,” he said.

QyScore was first commercialized in Europe after receiving CE mark approval in September 2017.

To obtain 510(k) clearance for a new medical device, a company must submit technical, safety, and performance information for that device to the FDA. The FDA then reviews this data and, if appropriate, clears the device for sale in the U.S.

“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.”