FDA approves 'smart pill'

Published date : 02 August 2012
Article date : 02 August 2012

The Ingestion Event Marker from Proteus Digital Health had been approved by the FDA. The ingestible sensor can transmit information on medication adherence and the patient's vital signs to medical professionals. 

The sensor is about the size of a grain of sand and made from silicon and ingredients found in food. It can be embedded in a pill and when swallowed, fluids in the stomach activate the sensor to communicate a signal to a wearable patch that marks the timing of ingestion. The battery-operated patch can also measure heart rate, temperature and activity but needs to be changed every seven days.
 
Data collected by the sensors is relayed to a mobile phone application where it can be accessed by caregivers and clinicians. The system was tested in areas including tuberculosis, mental health, heart failure, hypertension and diabetes. Patients taking medication for diabetes, central nervous system disorders and immune suppression after organ transplant are potential targets for the device.
 
The Ingestion Event Marker took four years to gain FDA approval. It achieved the CE Mark in 2010 and the company rolled out its first application in Europe with LloydsPharmacy earlier this year.
 
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