Neu Health Gets FDA Nod for Smartphone-Based Parkinson’s Tremor Tracker

The company also confirmed ongoing discussions with additional health systems and payer partners across the U.S.

Neu Health has received FDA 510(k) clearance for its smartphone-based tremor measurement module, marking its official entry into the U.S. healthcare market. The module is designed to quantify tremor in adults with mild to moderate Parkinson’s disease using only a smartphone, without any wearable or in-clinic hardware.

The platform is currently live at Mass General Brigham in Boston for Parkinson’s care. The company also confirmed ongoing discussions with additional health systems and payer partners across the U.S.

Dr. Kinan Muhammed, Chief Medical Officer of Neu Health, said, “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. 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 phone, we objectively and remotely track signs and symptoms. This helps close the gap between what’s observed during clinic appointments and what patients experience, providing a clearer understanding and a real opportunity to improve patient care.”

Neu Health claims the clearance is for “the first known fully phone-based system, with no wearable or in-clinic hardware, for measuring motor symptoms in Parkinson's care.”

The platform supports remote, app-based monitoring of disease progression through seven-minute assessments. It uses artificial intelligence and analytics to track motor and cognitive changes. The system can predict significant clinical outcomes 18 months before and includes remote clinician-guided care.

Additionally, the tool guides patients through tasks to analyze speech, movement, and memory, aiming to identify predictive digital biomarkers that detect early signs of neurological decline, potentially weeks or months before conventional tools.

Neu Health is built on the Oxford Discovery Cohort, a dataset with over a decade of real-world patient tracking specific to Parkinson’s disease.

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