FDA clears smart pills that monitor medication adherence

An ingestible sensor, formally referred to as the Ingestion Event Marker or IEM by Proteus Digital Health, that can report medication adherence and vital signs to physicians has been given the green light by FDA.

The IEM is part of the Proteus digital health feedback system, an integrated, end-to-end personal health management system that is designed to help improve patients’ health habits and connections to caregivers, according to a company press release.

The sensor, which is the size of a grain of sand, can be integrated into an inert pill or other ingested products, such as pharmaceuticals. Once the ingestible sensor reaches the stomach, it is powered by contact with stomach fluid and communicates a unique signal that determines identity and timing of ingestion. This information is transferred through the user’s body tissue to a patch worn on the skin that detects the signal and marks the precise time an ingestible sensor has been taken. Additional physiologic and behavioral metrics collected by the patch include heart rate, body position, and activity. The patch relays information to a mobile phone application. To view a demonstration video of the process, click here.

With the patient’s consent, the information is accessible by caregivers and clinicians, helping individuals to develop and sustain healthy habits, families to make better health choices, and clinicians to provide more effective, data-driven care.

“It could be used to document compliance especially if each medication had its own signature silicon-based chip,” said Formulary advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. “One wonders if insurance carriers or the government could use this to ensure compliance. Patients who are noncompliant would not be covered. With that in mind, issues like privacy and confidentiality become important. This may introduce more questions than answers.”

Proteus has worked collaboratively with the FDA since 2008 to determine the regulatory pathway for this innovation, which represents a new category of medical device and patient care. The application was ultimately processed in accordance with the de novo provisions of the Federal Food, Drug, and Cosmetic Act for low-risk devices that have no predicate on the market.