Proteus Digital Health Receives Clearance for Ingestible Sensor

Proteus Digital Health has an interesting new product on the market, just having received clearance from the U.S. Food and Drug Administration (FDA). The device is an ingestible sensor, able to be integrated in a pill or other edible vehicle. Formerly referred to as the ingestion event marker or IEM, the device 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 technology, 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 George M. Savage, M.D., co-founder and chief medical officer at Proteus Digital Health.

Eric Topol, professor of genomics at The Scripps Research Institute and author of “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare,” called the FDA validation a “major milestone in digital medicine.” He went on to say, “Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management.”

Once the ingestible sensor reaches the stomach, it is designed to be 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. 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.

In addition to being ingestible, the device is also a type of wireless technology, devices that have been under close scrutiny lately due to security concerns including the risk of hacking.

Based in Redwood City, Calif., Proteus Digital Health, Inc. is concerned with developing and commercializing digital health feedback technology that is integrated into ingestible products. Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Otsuka, ON Semiconductor and other investors.