Publication/Creation Date

May 14 2012

Creators/Contributors

Food And Drug Administration (FDA) (creator)
Proteus Digital Health (creator)

Description

FDA 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."

Location on Body

Digestive Tract, Skin

Augments

Treating, Testing, Regulating, Monitoring

Technology Keywords

Ingestible Event Marker (IEM) Sensor, Digital Pills, Patch, Software, Wireless Connectivity, Biometrics, Intra-body Communication

Keywords

Medical, Health, Regulation, Government, Big Pharma, Ethics

Marketing Keywords

Proteus Digital Health, Proteus Personal Monitor

Source

https://www.accessdata.fda.gov/cdrh_docs/reviews/K113070.pdf