FDA Clears Ingestible Event Marker System

The US Food and Drug Administration (FDA) has given the green light to the ID-Cap System, a real-time, dose-level ingestion event verification system.

Developed by etectRx, Inc., the system represents the only ingestible event marker able to transmit digital messages from within the body to an external receiver without needing direct skin contact.

The system includes the ID-Capsule, ID-Tag, ID-Cap Reader, and related software.

The ID-Capsule is a standard pharmaceutical capsule that contains the ID-Tag, an ingestible sensor that emits a low-power digital message from within the patient that is activated by stomach fluid.

The ID-Cap Reader can be worn on a lanyard to verify the message as a valid ingestion event and forward the data to a secure mobile application and to the healthcare provider in a secure-web-based portal.

"This is a historic event for etectRx and digital health," Harry J. Travis, president and CEO of etectRx, said in a statement. "It is the first product enabled by our proprietary in-vivo communication platform to gain clearance.”

Investigators at Brigham and Women's Hospital and Fenway Health are evaluating the system in ongoing and planned clinical studies focusing on HIV medication when used for treatment and prevention.

"We look forward to continuing our work with etectRx to assess the potential impact of the ID-Cap System on the health of patients, clinical decisions of healthcare providers, and goals of health systems," Kenneth H. Mayer, MD, medical research director and co-chair of the Fenway Institute at Fenway Health, said in a statement. "We need innovative solutions, including cleared medical devices such as the ID-Cap System, to better evaluate the challenges of medication non-adherence, which have the potential to be part of tailored interventions."

The ID-Cap System is classified by the FDA as an ingestible event marker and Class II medical device and will be available by prescription.