The notice, last updated Jan. 20, does not include any further information beyond classifying the device in the “transmitters and receivers, electrocardiograph, telephone” categories and listing its name as “Study Watch With Irregular Pulse Monitor.” Verily has yet to release an announcement about what appears to be expanded health monitoring capabilities for the device.
The FDA clearance was granted almost exactly one year after the Study Watch’s last regulatory notice, in which the prescription-only wearable was cleared to record, store, transfer and display users’ heart rhythms using an on-demand electrocardiogram feature.
The Study Watch was launched in 2017 for use in Verily’s health research projects. Since then, it has been used in the Project Baseline initiative to build a population health database, the Personalized Parkinson’s Project and more.
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