EtectRx this week announced that the FDA cleared its ID-Cap System ingestible event marker.
The ID-Cap System is an ingestible event marker that transmits digital messages from within the body to an external receiver.
EtectRx’s ID-Cap System features the ID-Capsule, ID-Tag, ID-Cap Reader and related software. It gives real-time dose-level ingestion event verification and the sensor emits a low-power digital message from inside the patient once ingested. The data from the event market is sent to a smartphone-based mobile application.
“This is a historic event for etectRx and digital health,” president and CEO Harry Travis said in a news release. “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.”
The company is currently working with researchers at Brigham and Women’s Hospital and Fenway Health to evaluate the use of the ID-Caps System in clinical studies focusing on HIV medication 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 Mayer, medical research director and co-char of the Fenway Institute, said. “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.”