FDA designates software for Parkinson's as Breakthrough Device
The Food and Drug Administration (FDA) has granted “Breakthrough Device” designation to nQ Medical for its neuroQWERTY brain health monitoring solution.
The designation is granted for “The neuroQWERTY software as a medical device platform intended to characterise abnormalities in psychomotor performance and fine motor function by analysing mechanical keyboard and touchscreen device interactions in adults with, or suspected of having, Parkinson’s Disease (PD).”
The approved use is for 24/7 remote patient monitoring of disease progression and measurement of the impact of therapy in PD patients to more effectively treat symptoms of the disease.
Although disease modifying therapies for PD are still in drug discovery phases, early detection, continuous disease progression management, and proper measurement of the effects of treatment can provide significant opportunity for better patient outcomes.
Rahul Mahajan, chief medical officer of nQ Medical, said: “The breakthrough device designation reaffirms that the nQ’s brain monitoring solution enables better treatment of patients by providing more precise and timely feedback to clinicians. The FDA’s recognition of enabling novel and effective digital therapies that demonstrate clinical evidence benefits helps the thousands of sufferers of Parkinson’s disease.”
nQ’s computational biomarker is characterised as software as a medical device (SaMD) and measures brain-finger connection activity via keystroke and touchscreen dynamics. It is the result of five clinical trials in six years and five peer-review clinical publications. Clinical data has demonstrated that nQ may be effective for diseases such as sleep inertia, substance inebriation, Alzheimer’s disease, and Parkinson’s disease. Further clinical trials are underway in mild cognitive impairment (MCI), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Concussion (mTBI).
R. A. Bavasso, co-founder and CEO of nQ Medical, said: “Everyone has a unique typing and touchscreen signature. Research has revealed that the way we interact with computers and mobile devices can reveal with startling accuracy the presence of certain neuromotor, neurocognitive, and neurobehavioral disorders.”
The nQ platform was developed in conjunction with the Massachusetts Institute of Technology and funded, in part, by the Michael J. Fox Foundation to deliver a validated artificial intelligence tool to open a broad opportunity to better diagnose disease(s), use real-world evidence to monitor disease progression, and track therapeutic intervention effectiveness.