November 19, 2017

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FDA Approves First Digital Pill That Can Track If You've Taken It

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The FDA has approved the first drug with “a digital ingestion tracking system.” Abilify MyCite is an antipsychotic with an ingestible sensor that transmits data to a patch, which then sends the information to a smartphone app. Proteus Digital Health hide caption

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The Food and Drug Administration has approved its first digital drug: a pill embedded with a sensor that transmits whether someone has taken it.

Although the approval is a big step for digital medicine, there are concerns about privacy, convenience and cost.

The tablet and embedded sensor is called Abilify MyCite. Abilify, made by Japan-based Otsuka Pharmaceutical, is the brand-name version of aripiprazole, an antipsychotic drug used for treating schizophrenia, bipolar disorder and as an add-on treatment for depression in adults.

The tiny sensor, made by a company called Proteus, is about the size of a grain of sand. It’s activated when it comes into contact with fluid in the stomach. The sensor detects and records the date and time the pill is ingested.

The sensor transmits that data to a patch worn by the patient. The patch then sends the data to

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