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FDA Grants Breakthrough Device Designation to nQ Medical for Parkinson's Disease Management Platform


The FDA has granted "Breakthrough Device" designation to Cambridge MA based nQ Medical for remote patient monitoring of disease progression with its brain health monitoring solution. The platform is intended to characterize abnormalities in fine motor function by analyzing touchscreen keyboard interactions in adults with, or suspected of having, Parkinson's Disease. The approved use is for 24/7 remote patient monitoring designed to measure disease progression and impact of therapy.

WASHINGTON (PRWEB) February 06, 2020

The U.S. 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 characterize abnormalities in psychomotor performance and fine motor function by analyzing 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, a challenge for movement disorder specialists today as they routinely only see one to two times a year.

PD is a debilitating chronic condition that affects millions of lives globally. 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. "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, "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."

There is rich information hidden in the way our fingers interact with smart devices that allows for cognitive and motor impairment tracking and early detection of neurodegenerative disease onset. nQ's computational biomarker is characterized as software as a medical device (SaMD) and measures brain-finger connection activity via keystroke and touchscreen dynamics. It is the result of 5 clinical trials in six years and 5 peer-review clinical publications and promises to be an effective indicator of neuromotor and neurocognitive brain condition. 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).

"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," commented R. A. Bavasso, Co-Founder and CEO of nQ Medical. 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.

Machine learning algorithms detect subtle psychomotor impairment typical of these diseases by analyzing the timing of keystrokes and device pressure. Consistent with HIPAA, no information on what is typed/touched is captured, only "how" it is typed/touched. No investment in a proprietary device or no unnatural tasks are required. "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," added Bavasso. The AI tool provides unified data management across the entire clinical lifecycle, from clinical trials to physician dashboards, from patient engagement to population health allowing for a completely integrated experience. The machine learning approach provides a complete perspective from individual baseline data.

nQ may aid in the diagnosis of neurodegenerative disease earlier than current gold standard tools. (Read the Clinical Studies). Physicians can now prescribe Rx with confidence, having unparalleled access to 24/7 real-time data from patient's personal devices. With earlier diagnosis, granular tracking of disease progression, and ongoing measurement of therapeutic impact, nQ reveals insights to help the clinician "see" what is happening with their patients in real time.

About the FDA Breakthrough Devices Program

The FDA Breakthrough Devices Program is a voluntary program for medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To learn more, visit the FDA page here.

About Parkinson's disease

More than 10 million people worldwide are living with PD. Approximately 60,000 Americans are diagnosed with PD each year. The combined direct and indirect cost of PD, including treatment, social security payments and lost income, is estimated to be nearly $25 billion per year in the United States alone. To learn more, visit the Michael J. Fox Foundation here.

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