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Proteus Ingestible Sensor for Tracking Medication Intake Receives FDA Clearance

July 31st, 2012 Wouter Stomp GI, Medicine


Proteus Digital Health has received FDA clearance for its ingestible sensor. The sensor (formally referred to as the Ingestion Event Marker or IEM) is part of the Proteus digital health feedback system, which also includes a wireless skin patch (previously called Raisin Personal Monitor) with which the sensor communicates. The sensor can be integrated into ingested products such as pharmaceuticals, to track when one actually swallows one of these substances.

The sensor measures 1mm square and is made mostly of silicon. It does not contain a battery, but is powered for a short amount of time by contact of two conductive materials with stomach acid. It sends a signal to the skin patch at the moment it reaches the stomach allowing the patch to record the exact time medication is taken, as well as the unique identity of that medication.

Besides communicating with the ingestible sensor, the patch records heart rate, temperature, activity and rest patterns. The patch is battery-operated and lasts approximately seven days, after which it must be replaced.

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.

Press release:Proteus Digital Health Announces FDA Clearance of Ingestible Sensor…

Product page: The Proteus Digital Health Feedback System…

Flashbacks: Proteus Pill Ingestion Monitoring System Gets EU Green Light; Novartis’ Pill Microchip Enables Remote Monitoring of Drug Dosage and Efficacy

Wouter Stomp

Wouter Stomp is a radiology resident at the radiology department of Leiden University Medical Center, the Netherlands. He is also a PhD candidate with his research focussing on the role of MRI in early rheumatoid arthritis.

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