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Medical Devices / Submissions and Approvals

Pioneering Digital Pill Receives FDA Approval

Nov. 16, 2017
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The FDA granted its first-ever approval to a prescription pill containing a sensor that verifies ingestion via electronic detection.

When activated by contact with stomach fluids, the sensor, imbedded in an Abilify (aripiprazole) MyCite antipsychotic tablet, sends a signal to a patch worn on the patient’s skin, with the data transmitted to a smart phone application.

The system records the date and time of ingestion and additional information about the patient’s activity level when the pill is taken. The patient can consent for a health-care provider, family members or others to access that information through a web portal and can add more information, such as a report on mood.

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