The ID-Cap system provides real-time, dose-level ingestion event verification
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Digital health company etectRx has secured approval from the US Food and Drug Administration (FDA) for its patented ingestible event marker called ID-Cap system.
The ID-Cap System is claimed to be the first and only ingestible event marker that can transfer digital messages from within the body to an external receiver without direct skin contact for recording ingestion events.
ID-Cap system offers real-time and dose-level ingestion event verification
Featuring ID-Capsule, ID-Tag, ID-Cap Reader and related software, the ID-Cap system offers real-time and dose-level ingestion event verification.
The ID-Capsule is a standard pharmaceutical capsule that features the ID-Tag, an ingestible sensor that radiates 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, authenticates the message as a valid ingestion event and forwards the data to a secure smartphone-based mobile application, as well as to the healthcare provider in a secure web-based portal.
Digital health firm’s advanced communication technology will facilitate to incorporate the receiver into a variety of wearable and off-body devices in the future.
The firm is developing relations with healthcare providers, health systems, pharmacies, pharmaceutical manufacturers, and clinical research organisations to integrate the new technology with future digital medications and other valuable applications in the medical, pharmaceutical, and consumer markets.
Brigham and Women’s Hospital and Fenway Health researchers are assessing the ID-Cap system in ongoing and planned clinical studies, with a focus on HIV medication when used for treatment and prevention.
etectRx president and CEO Harry Travis said: “This is a historic event for etectRx and digital health.
“It is the first product enabled by our proprietary in-vivo communication platform to gain clearance. We are excited about the many opportunities that the ID-Cap System will provide patients and clinicians to improve therapeutic outcomes and deliver better care.”
In November this year, Ultromics secured 510(k) clearance from the FDA for its EchoGo Core image analysis system.