Neu Health, a smartphone platform for Parkinson's disease and dementia, announced it received FDA 510(k) clearance for its smartphone-based tremor measurement module, which aims to quantify tremor in adults with mild to moderate Parkinson's disease.
The FDA clearance marks the company's formal entry into the U.S. market, where the platform is currently live for Parkinson's care at Mass General Brigham in Boston.
The company said it is in active discussions with other health systems and payer partners throughout the U.S.
"Parkinson’s disease isn’t just a tremor in one hand, it impacts many other areas, including speech, dexterity, balance and cognition, often in ways that fluctuate over time," Dr. Kinan Muhammed, CMO of Neu Health, told MobiHealthNews.
"To truly support clinical decisions, we need to capture this full picture. That’s why we built Neu Health around a multimodal, smartphone-based approach. Using the sensors in a patient’s own phone, we objectively and remotely track signs and symptoms. This helps close the gap between what’s observed during clinic appointments and what patients actually experience, providing a clearer understanding and a real opportunity to improve patient care."
According to the company, the FDA clearance marks "the first known fully phone-based system, with no wearable or in-clinic hardware, for measuring motor symptoms in Parkinson's care."
The platform and patient program are also designed to monitor and translate digital measures of clinically relevant symptoms, thereby optimizing condition management, reducing clinician burden and ultimately improving outcomes.
Among its features are patient-centric, app-based remote monitoring of disease progression, which requires seven minutes of patient input, artificial intelligence/machine learning, along with analytics to accurately measure progression and predict significant clinical outcomes 18 months in advance. The offering also features remote clinician-guided management.
Additionally, Neu guides Parkinson's and dementia patients through brief, organized tasks that analyze speech, movement and memory, aiming to generate predictive biomarkers that flag early signs of neurological decline weeks or months before traditional tools detect a problem.
Neu Health is built on the Oxford Discovery Cohort, a longitudinal dataset on Parkinson's with more than 10 years of real-world patient tracking.
Parkinson's disease impacts more than one million Americans today and that number is projected to grow 20% by 2030. Dementia affects over 6 million people in the U.S., with global cases expected to triple by mid-century.
