www.fdanews.com/articles/195755-fda-clears-qynapses-brain-mri-analysis-software
FDA Clears Qynapse’s Brain MRI Analysis Software
February 4, 2020
Qynapse received 510(k) clearance for its QyScore software, which analyzes brain MRIs for early markers of neurogenerative diseases including Alzheimer’s, Parkinson’s and multiple sclerosis.
The software automatically generates patient reports in minutes and compares them with a database of healthy subjects.
“QyScore is compatible with the clinical routine workflow to support differential diagnosis and measure of clinical progression and also used in clinical trials for monitoring of drug efficacy and safety,” the company said.