Smartphone-Based Tremor Monitoring System For People with Parkinson’s Cleared by FDA

The Food and Drug Administration (FDA) has granted 510(k) clearance to Neu Health’s (Oxford, England, United Kingdom) smartphone-based tremor assessment module. The device is designed to enable clinicians to remotely quantify tremor severity in adults with mild-to-moderate Parkinson disease (PD) without the need for wearable devices or in-clinic hardware. Neu Health stated that their platform is already in use at Mass General Brigham hospital in the United States.

The broader Neu Health platform guides patients through structured at-home assessments designed to capture subtle changes in speech, memory, movement, and cognition. Using smartphone sensors and predictive analytics trained on data from the Oxford Parkinson's Disease Centre Discovery Cohort, the system generates digital biomarkers and composite scores to support early detection and intervention, potentially detecting changes ≥18 months earlier than traditional assessment, according to data from the UK deployment. The system is integrated into electronic health records (EHRs) and supports Remote Therapeutic Monitoring (RTM) billing.

“People often overlook voice or gait changes because they assume they’re minor, but they’re among the earliest and most actionable signals of neurological decline,” said Dr. Kinan Muhammed, Cofounder and Chief Medical Officer of Neu Health. “By capturing these subtle shifts longitudinally and objectively, Neu allows us to anticipate deterioration, personalize treatment and reduce the burden on patients, caregivers and care teams alike.”