FDA Approves Ingestible Digital Sensor that Tracks Medication Adherence | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Approves Ingestible Digital Sensor that Tracks Medication Adherence

August 2, 2012
by Gabriel Perna
| Reprints

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.



Survey: By 2019, 60% of Medicare Revenues will be Tied to Risk

Medical groups and health systems that are members of AMGA (the American Medical Group Association) expect that nearly 60 percent of their revenues from Medicare will be from risk-based products by 2019, according to the results from a recent survey.

83% of Physicians Have Experienced a Cyber Attack, Survey Finds

Eighty-three percent of physicians in a recent survey said that they have experienced some sort of cyber attack, such as phishing and viruses.

Community Data Sharing: Eight Recommendations From San Diego

A learning guide focuses on San Diego’s experience in building a community health information exchange and the realities of embarking on a broad community collaboration to achieve better data sharing.

HealthlinkNY’s Galanis to Step Down as CEO

Christina Galanis, who has served as president and CEO of HealthlinkNY for the past 13 years, will leave her position at the end of the year.

Email-Related Cyber Attacks a Top Concern for Providers

U.S. healthcare providers overwhelmingly rank email as the top source of a potential data breach, according to new research from email and data security company Mimecast and conducted by HIMSS Analytics.

Former Health IT Head in San Diego County Charged with Defrauding Provider out of $800K

The ex-health IT director at North County Health Services, a San Diego County-based healthcare service provider, has been charged with spearheading fraudulent operations that cost the organization $800,000.