Proteus Digital Health announced today that the FDA has cleared its ingestible sensor for marketing as a new category of medical device. This is part of the Proteus digital health feedback system designed to improve patients’ health habits and connection to caregivers.

The Proteus ingestible sensor (formerly known as the Ingestion Event Marker [IEM]) can be integrated into an inert pill or other ingested products. Once the ingestible sensor reaches the stomach, contact with stomach fluid allows the communication of a unique signal that determines identity and timing of ingestion. This information is then transferred through the user’s body tissue to a patch worn on the skin that detects the signal and marks the exact time an ingestible sensor has been taken.

Additional physiologic and behavioral metrics collected include heart rate, body position and activity. The patch can also relay information to a mobile phone application. With the patient’s consent, the information is accessible by caregivers and clinicians.

The Proteus ingestible sensor is expected to be available in September 2012.

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