Digital medicines: clinical review on the safety of tablets with sensors

摘要

Following the landmark regulatory approval of digital aripiprazole (Abilify Mycite?) late in 2017, digital medicines have begun the transition from clinical trials and early clinical success to mainstream utilization. The ingestible sensor enabling the era of Digital Medicines was originally approved in 2012 via FDA’s de novo pathway for novel low-risk devices; commercial use began shortly thereafter. The clinical significance of the 2017 NDA approval is challenging to overstate, given the rarity of new pharmaceutical categories and the safe incorporation of the Proteus ingestible event marker (IEM) into the manufacturing process of the pharmaceutical industry.