Neu Platform
Neuhealth Digital Ltd.The Neu Platform is a smartphone application and clinician dashboard system designed to remotely measure and quantify tremor severity in patients aged 45 or older with mild to moderate Parkinson's Disease. It collects motion data via smartphone accelerometers, allowing patients to perform motor assessments and report symptoms remotely, while clinicians can review this data in a secure web portal to monitor and manage the patient's condition more effectively.
Intended Use
The Neu Platform is intended to quantify the kinematics of movement disorder symptoms, including tremor in adults (45 years and older) with mild to moderate Parkinson's disease.
Technology
The Neu Platform includes a patient smartphone app that uses accelerometers in commercial digital devices to remotely capture tremor measurements and patient-reported symptoms, and a clinician web-based dashboard for data review. Data is transmitted via cloud infrastructure and encrypted. The device functions as a stand-alone software system on off-the-shelf mobile hardware.
Performance
Performance testing showed that tremor measurements from the Neu Platform have strong correlation (0.85 to 0.92) with clinical standard tremor severity scales (MDS-UPDRS), demonstrating accuracy comparable to a predicate device. No animal or clinical study performance data was included; equivalence based on non-clinical bench testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/21/2025
3 months - 2
FDA Approval
4/25/2025
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