The U.S. Food and Drug Administration (FDA) has approved of an ingestible digital sensor that is used to transmit patient data to track medication adherence, according to a press release from the company that is marketing the device. The company, Redwood City, Calif.-based Proteus Digital Health, Inc., announced that the ingestible sensor, referred to as the Ingestion Event Marker, has been approved by the FDA after the company worked with the agency for several years to determine a regulatory pathway.
“We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe,” Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health, said in a statement. “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 device, which is a part of the Proteus digital health feedback system that aims to improve patients’ health habits and connections to caregivers, is already approved in Europe. The pill is as small as a grain of sand and can be integrated into an inert pill or other ingested products, such as pharmaceuticals. According to Proteus, once the sensor reaches the stomach, it is powered by contact with stomach fluid and communicates a unique signal that determines identity and timing of ingestion.
The information is then transferred through the user’s body tissue to a patch worn on the skin, which detects the signal and marks the precise time an ingestible sensor has been taken, Proteus says. It relays the information to a mobile phone app. This is all done with the patient’s permission. Cost has not yet been determined.