Mental Health

FDA Approves Proteus' Ingestible Sensor

By Staff Reporter | Update Date: Aug 02, 2012 10:43 AM EDT

There is now a new way for your doctor to make sure you take your medication.

The U.S. Food and Drug Administration (FDA) has cleared an ingestible sensor for marketing as a medical device. The ingestible sensor is part of the Proteus digital health feedback system designed to help improve patients' health habits and connections to caregivers.

"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."

The ingestible sensor 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.

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.

Eric Topol, director of the Scripps Translational Science Institute in La Jolla,California told Nature.com that this new device is "like big brother watching you take your medicine."

"About half of all people don't take medications like they're supposed to," Topol said "This device could be a solution to that problem, so that doctors can know when to rev up a patient's medication adherence."

Proteus has worked collaboratively with the FDA since 2008 to determine the regulatory pathway.

"The FDA validation represents a major milestone in digital medicine. 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," said Dr. 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".

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