FDA Clears etectRx’s Ingestible Event Marker

The FDA granted 510(k) clearance for etectRx’s ID-Cap system, a device that wirelessly transmits signals of drug ingestion events to a mobile app-linked receiver.

The device, a gelatin capsule containing a wireless ingestible sensor, sends low-power digital signals of drug ingestion events to an external receiver, eliminating the need for direct skin contact.

The device’s reader component, worn on a lanyard, verifies that the sensor’s message is a valid drug ingestion event and then sends the data via Bluetooth to a mobile app and healthcare provider portal.