neuroQWERTY For Diagnosing, Tracking Parkinson’s Wins FDA Breakthrough Device Designation

Parkinson’s disease doesn’t have many treatment options, but early detection and monitoring of its progression can bring important benefits to patients. However, most Parkinson’s patients are rarely assessed by movement disorder specialists and those only suspected of having the disease don’t have any tools to help them detect changes in movement while outside a clinic.

Now, the FDA has granted Breakthrough Device designation to nQ Medical, a firm based in Cambridge, MA, for its neuroQWERTY software that monitors psychomotor performance and fine motor function while a person uses their computer or smartphone. The software runs in the background and the person being monitored doesn’t have to do anything other than continue using the device running the neuroQWERTY software as they always have.

The software monitors how each key is pressed or how the phone is tapped to spot changes in how the user’s fingers are behaving. neuroQWERTY doesn’t actually track what is being done on the device, but rather how it is being physically utilized, which should alleviate any privacy concerns.

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

The FDA’s decision follows five clinical trials and as many peer-reviewed clinical publications of neuroQWERTY that showed that it can help assess neuromotor and neurocognitive brain function. Since some other diseases besides Parkinson’s also involve changes in brain activity, such as ALS, MS, and Alzheimer’s, nQ Medical’s algorithms may help with tracking those diseases as well.

“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.

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