FDA Grants Breakthrough Device Designation for nQ Medical’s neuroQWERTY

FDA Grants Breakthrough Device Designation for nQ Medical’s neuroQWERTY

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.

“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,” Rahul Mahajan, MD, chief medical officer of nQ Medical, said in a press release.

The neuroQWERTY software measures how fast a person is typing on a smart device and how much pressure they apply to each key. An artificial intelligence method called machine learning can detect small changes in the typing movements, which it can associate with different diseases such as Parkinson’s. The software does not record the words that were typed, only the patterns associated with the typing action.

“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,” said R.A. Bavasso, co-founder and CEO of nQ Medical.

NeuroQWERTY can be used with any keyboard, tablet or smart phone. This allows for round-the-clock monitoring of disease progression and treatment effectiveness without going to the clinic. This is a significant improvement from the current standard of care where patients see movement disorder specialists only once or twice a year.

“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,” Bavasso said.

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.

The nQ platform was developed at the Massachusetts Institute of Technology and funded partly by the Michael J. Fox Foundation, with the goal of creating an artificial intelligence tool to diagnose and monitor disease progression and track therapeutic effectiveness.

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.

That study is still recruiting participants. More information can be found here.

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

“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,” Mahajan said.