etectRx, a digital health company based in Florida, received U.S. FDA 501(k) clearance of its breakthrough patented ingestible event marker, the ID-Cap System.
The ID-Cap System the first ever ingestible event marker that potentially gives clinicians the ability to accurately monitor patients’ medication adherence on a per-dose basis. Each time an ID-Capsule is swallowed, the ID-Tag uses etectRx’s proprietary communications technology to transmit a very low power digital message from within the patient’s stomach.
“This is a historic event for etectRx and the larger digital health market,” said Harry J. Travis, president and CEO of etectRx. “It is the first product enabled by our proprietary in-vivo communication technology platform to gain clearance. We are very excited about the many opportunities that the ID-Cap System will provide patients and clinicians to improve therapeutic outcomes and deliver better care.”
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 incorporation of the receiver into a variety of wearable and off-body devices in the future, reports etectRx.
The company is building collaborations with key stakeholders, including healthcare providers, health systems, pharmacies, pharmaceutical manufacturers, and clinical research organizations, to bring this innovative technology to digital medications of the future.
Researchers at Brigham and Women’s Hospital and Fenway Health are evaluating the ID-Cap 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,” said Kenneth H. Mayer M.D., medical research director and co-chair of the Fenway Institute at Fenway Health. “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.”