Neu Health, a smartphone-based platform focused on Parkinson’s disease and dementia, has received FDA 510(k) clearance for its tremor measurement module, marking its official entry into the U.S. market. The tool quantifies tremor in adults with mild to moderate Parkinson’s disease using only a smartphone—no wearables or in-clinic hardware required. The platform is already live at Mass General Brigham in Boston, with ongoing discussions underway with other U.S. health systems and payers.
Neu Health uses a multimodal, app-based approach to remotely and objectively track a wide range of symptoms, including speech, movement, balance, and cognition, all through a patient’s own smartphone. Designed to bridge the gap between in-clinic observations and real-world experiences, the platform supports better clinical decision-making and improved care.
The system features AI-driven remote monitoring and analytics that require just seven minutes of patient input, aiming to measure disease progression and predict meaningful clinical outcomes up to 18 months in advance. Patients complete brief tasks analyzing speech, memory, and motor function to help detect early signs of neurological decline, potentially weeks or months before traditional methods.
Built on the Oxford Discovery Cohort—one of the largest longitudinal Parkinson’s datasets with over a decade of patient tracking—Neu Health is designed to reduce clinician burden while enhancing patient outcomes. Parkinson’s currently affects over one million Americans, a number expected to grow by 20% by 2030. Dementia impacts more than 6 million in the U.S., with cases projected to triple globally by mid-century.
Click here to read the original news story.