... of a digital health technology using wrist-worn PPG sensors and an ML-based algorithm to measure PR continuously. Methods: Volunteers were enrolled in three independent clinical trials and concurrently monitored with the investigational device and FDA-cleared electrocardiography (ECG) devices during supervised...

...; COU, context of use; IU, intended use; DHT, digital health technology; PK/PD, pharmacokinetic and pharmacodynamics (Simplification of CTTi Flowchart of Steps for Novel Endpoint Development [ 16 ]). The regulatory classification of DHTs (i.e., medical device or not) and its intended use...

.... This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors...