The US Food and Drug Administration (FDA) has cleared an ingestible medical device manufactured by Proteus Digital Health through its de novo clearance pathway, clearing the way for the futuristic device to get to market.
The de novo process is used for low-risk novel devices that would otherwise be required to submit a premarket approval (PMA) application and be subjected to expensive clinical trials.
Proteus' device, the Ingestion Event Marker (IEM), was described by the company in a statement as a "digital health feedback system … designed to help improve patients' health habits and connections to caregivers."
The device has been in development since at least 2008, during which time Proteus said it worked closely with FDA regulatory officials to determine the appropriate regulatory pathway for the device. The device had already obtained European Conformity (CE) marking in Europe, allowing it to be legally marketed there.
Potential to Boost Adherence and Change Clinical Trials
The silicon-based device is described by its manufacturer as being a 1mm diameter sphere and is powered by the body's own electricity, "Just like a potato battery," remarked Proteus. Data obtained by the device is then passed on to a patch worn by the user, which tracks a variety of data including what time a medication is taken, the type of medication taken and other biometric data.
Data collected is then available in a smart phone application, which may be shared with the user's physician or other healthcare providers.
The device is designed to be included within pharmaceutical products to allow both patients and physicians to track rates of prescription drug adherence. The company notes approximately half of all patients do not take their medication as prescribed, and their new "digital medicines" system could go a long way toward increasing rates of patient adherence.
This could be of substantial benefit to sponsors of clinical trials, who would be able to determine exactly what medications were taken and at what time, potentially without requiring expensive clinical trial infrastructure to conduct the trials.
Proteus - Proteus Digital Health Announces FDA Clearance of Ingestible Sensor