Evaluation of Automatic Class III Designation (De Novo) for Proteus Personal Monitor Including Ingestion Event Marker
Publication/Creation DateMay 14 2012
DescriptionFDA summary of Proteus' Ingestible Event Marker, including regulatory information, background information, device description, safety testing studies, and a summary of the clinical information.
"The Proteus Personal Monitor, also called the “Patch”, is a body-worn sensor that collects physiological and behavioral metrics including heart rate, activity, body angle and time-stamped user-logged events generated when a user marks an event by swallowing an Ingestion Event Marker (IEM) or by manually pressing an event marker button on the Patch. The Patch stores and wirelessly sends the IEM data to a general computing device. The Proteus Personal Monitor Including Ingestion Event Marker system is comprised of three main subsystems; (1) the ingestion event marker (IEM), (2) the data recorder (Patch), and (3) the Proteus software."
Date archivedOctober 30 2020
Last editedNovember 3 2020
How to cite this entry
Food and Drug Administration (FDA), Proteus Digital Health. (May 14 2012). "Evaluation of Automatic Class III Designation (De Novo) for Proteus Personal Monitor Including Ingestion Event Marker". Food and Drug Administration (FDA). Fabric of Digital Life. https://fabricofdigitallife.com/Detail/objects/4975