Proteus Digital Health

FDA asks for more tests before it approves Proteus-Otsuka’s sensor-equipped pill

The two companies submitted the system as a new drug application (NDA) with the FDA in September 2015, and the Agency now declined to approve it.
Abilify bottle

First digital medicine starts its journey with the FDA

A drug/device product combines Otsuka's ABILIFY for serious mental illness, embedded with the Proteus ingestible sensor in a single tablet to record ingestion.