FDA clears the "smart pill" by Proteus Digital Health (ingestible sensor)

Tuesday, July 31, 2012

This was announced yesterday:

Proteus Digital Health Announces FDA Clearance of Ingestible Sensor

REDWOOD CITY, Calif. – July 30, 2012 – Proteus Digital Health, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its ingestible sensor for marketing as a medical device. The ingestible sensor (formally referred to as the Ingestion Event Marker or IEM) is part of the Proteus digital health feedback system, an integrated, end-to-end personal health management system that is designed to help improve patients’ health habits and connections to caregivers.

The Proteus ingestible sensor can be integrated into an inert pill or other ingested products, such as pharmaceuticals. Once the ingestible sensor reaches the stomach, it is powered by contact with stomach fluid and communicates a unique signal that determines identity and timing of ingestion. This information is transferred through the user’s body tissue to a patch worn on the skin that detects the signal and marks the precise time an ingestible sensor has been taken. Additional physiologic and behavioral metrics collected by the patch include heart rate, body position and activity. The patch relays information to a mobile phone application. With the patient’s consent, the information is accessible by caregivers and clinicians, helping individuals to develop and sustain healthy habits, families to make better health choices, and clinicians to provide more effective, data-driven care.

Learn more here.

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