etectRx Announces U.S. FDA Clearance of Novel Ingestible Event Marker

UF Innovate | The Hub resident company etectRx^®, Inc., a privately-held digital health company, announced U.S. Food and Drug Administration (FDA) clearance of its breakthrough patented ingestible event marker, the ID-Cap^® System.

The ID-Cap System is the first and only ingestible event marker to transmit digital messages from within the body to an external receiver without the need for direct skin contact for the purpose of recording ingestion events.

Comprised of the ID-Capsule, ID-Tag, ID-Cap Reader, and related software, the ID-Cap System provides real-time, dose-level ingestion event verification. The ID-Capsule is a standard pharmaceutical capsule containing the ID-Tag, an ingestible sensor that emits a very low-power digital message from within the patient after it is ingested and activated by the patient’s stomach fluid. The ID-Cap Reader (worn on a lanyard) verifies the message as a valid ingestion event and forwards the data to a secure smartphone-based mobile application and to the healthcare provider in a secure web-based portal. etectRx’s advanced communication technology will allow for the incorporation of the receiver into a variety of wearable and off-body devices in the future.

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