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FDA rejects Verily filing for wrist-worn Parkinson’s clinical trial device

June 14, 2021

In recent years, FDA has cleared Verily’s Study Watch for use as an electrocardiogram and as an irregular pulse monitor via its 510(k) pathway. Verily followed up by filing to use the device as a drug development tool for Parkinson’s disease.

The new feature is an exam that patients can do at home in less than 20 minutes to assess their performance against Part III of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). MDS-UPDRS Part III assesses the motor function of Parkinson’s patients by testing variables including their ability to tap their index finger to their thumb quickly and repeatedly.

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