The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to nQ Medical’s neuroQUERTY software, which is designed to monitor brain health and Parkinson’s disease progression.

Breakthrough device status is given to medical devices that have the potential to be an effective treatment or diagnostic tool for life-threatening or irreversibly debilitating diseases. The status speeds the review and assessment process so the devices can reach the market faster.

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. Just live your life as you normally do with your chosen personal device and we can collect and feed back to you and your physician the status of your brain health.
R.A. Bavasso, co-founder and CEO of nQ Medical

The software could speed diagnosis of neurodegenerative diseases, which would lead to earlier intervention and better clinical outcomes. The effect of new and existing therapies also can be monitored more closely, allowing doctors to quickly understand which treatment works best for each patient.

Five studies using neuroQWERTY have been published and five clinical trials have assessed this technology so far.

One clinical trial (NCT02522065) evaluated the use of the neuroQWERTY approach in an uncontrolled at-home setting, by analyzing the baseline data collected from participants who were diagnosed less than five years ago and were about to initiate dopaminergic therapy. The technology was able to distinguish Parkinson’s patients from healthy individuals through the analysis of at-home typing patterns, and had a comparable performance to that performed in the clinic.

Another trial (NCT04101968) is currently using neuroQWERTY as one of its diagnostic tests to link the relationship between gamma-aminobutyric acid (GABA) mutations — known to increase the risk of developing Parkinson’s— and Parkinson’s disease. The trial may help researchers understand the changes that take place in the brain of people with GBA-related Parkinson’s disease, especially during the early stages of the disease.

More trials are planned in mild cognitive impairment (MCI), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and concussion (mTBI, or mild traumatic brain injury).


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