Digital Health Briefings

FDA-approved Digital Pill from Proteus Digital Health

Digital pills have already been used in practice for a while now. The FDA issued its first approval of a digital pill from Proteus Digital Health in 2017. Studies showed that such pills could improve treatment adherence among populations with adherence issues.

The technology is proven, and a few companies are working on similar solutions. EtectRx’s ID-Cap System is an end-to-end solution for real-time monitoring and tracking of every patient’s oral medication adherence in a clinical study. EtectRx’s digital pill gained FDA approval in 2019. The ID-Capsule is a standard hard gelatin capsule with an embedded ingestible wireless sensor – the ID-Tag. Each time an ID-Capsule is swallowed, the ID-Tag uses etectRx’s proprietary communications technology to transmit a very low-power digital message from within the patient’s stomach. It looks, tastes and feels like an ordinary capsule. The communication between the ID-Tag and the Reader results in every ingestion being detected. It is also a self-powered technology: the ID-Tag is powered by the patient’s stomach fluids. After the capsule dissolves, the ultra-thin, flexible sensor is naturally eliminated through the patient’s GI tract and leaves no trace. 

The Reader is a wearable device that detects messages transmitted from ingested ID-Tags and forwards them, using Bluetooth technology to the ID-Cap App on the patient’s smartphone. Necklace and wristband options are available for patients. They can put it on the wireless charging pad to recharge and take off between doses. The Reader does not require adhesives or direct contact with the skin to receive messages. The ID-Cap App relays the messages received by the Reader to the cloud-based secure server. 

Through individual patient management, clinicians can view, track and trend patient ingestion events in real time. Using the ID-Cap System allows for efficient analysis of ingestion events across large groups of patients. ID-Cap has produced approving results with high patient engagement in COVID-19 studies. etectRx evaluated patient engagement with the ID-Cap System on 1,270 use days. 

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