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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 patients’ 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.
“We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe,” said Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health. “We are very much looking forward to bringing the benefits of our ingestible sensor to the American public in the form of innovative product offerings.”
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 individual’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.