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Proteus Digital Health announced Monday that the FDA cleared its ingestible sensor Ingestion Event Marker, which can be integrated into an inert tablet or other ingested product, such as a drug. The company noted that the device is part of its feedback platform, an integrated, end-to-end personal health management system that is designed to help improve patients' health habits and connections to caregivers.
George M. Savage, Proteus' chief medical officer, said the company was pleased "to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe," where it received a CE mark in August 2010. The company indicated that it has worked with the FDA since 2008 to determine the regulatory pathway for the ingestible sensor, which it noted "represents a new category of medical device."
According to Proteus, once the device reaches the stomach, it is powered by contact with stomach fluid and communicates a signal that determines identity and timing of ingestion. This information is transferred to a skin patch, which can also collect heart rate, body position and activity information. The patch relays the information to a mobile phone application that can be accessed by caregivers and clinicians.
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