Proteus Digital Health recently declared that its ingestible sensor has achieved clearance from the U.S. Food and Drug Administration (FDA) for being marketed as a medical device.
Previously known as the Ingestion Event Marker or IEM, this ingestible sensor is a major component of Proteus digital health feedback system. The main focus of this integrated, end-to-end personal health management system is to support caregivers to bring improvement in patients’ health habits.
Since 2008, Proteus has partnered with the FDA for achieving a regulatory pathway for this innovation. A new category of medical device and patient care has been characterized in this novel system. Eventually, this application was processed with respect to the de novo provisions of the Federal Food, Drug and Cosmetic Act that supports low-risk devices void of market implication.
The Proteus ingestible sensor can be incorporated within an inert pill or other ingested products like pharmaceuticals. On entering the stomach, this ingestible sensor is driven by mixing with stomach fluid. A unique signal will be generated, through which the identity and timing of ingestion can be determined. This information will reach a signal-detecting patch worn on the skin via the user’s body tissue. The time taken by the ingestible sensor can also be determined. The patch also collects supplementary physiologic and behavioral patterns such as body position, heart rate, and activity. The patch passes on the information to a mobile phone application. The information can be accessed by caregivers and clinicians with patient’s approval, through which individuals can have better healthy habits, fostering improved health choices for patients and encouraging clinicians to offer efficient, data-driven care.
Source: http://proteusdigitalhealth.com/