Proteus Digital Health, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its ingestible sensor for marketing as a medical device. The ingestible sensor (formally referred to as the Ingestion Event Marker or 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 patientsâ€™ health habits and connections to caregivers.
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.
â€œWe are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe,â€ said Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health. â€œWe are very much looking forward to bringing the benefits of our ingestible sensor to the American public in the form of innovative product offerings.â€
Proteus Digital Health, Inc. is developing and commercializing digital health feedback technology that is integrated into ingestible products. This provides an unprecedented view into an individualâ€™s personal health choices and physiologic response, allowing patients to better manage their health and more effectively collaborate with caregivers and clinicians, while enabling new information-based business models.