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"A Major Milestone in Digital Medicine:" FDA Clears Ingestible Smart Pill

Proteus Digital Health Inc. (Redwood City, CA) has announced that FDA has cleared its swallow-able sensor, which can be integrated into a pill to monitor medication adherence. The de novo medical device, which the company refers to as an ingestible event marker (IEM), can monitor the timing of drug ingestion in the stomach and relay that information to caregivers.

bubble patchProteus Digital Health Inc. (Redwood City, CA) has announced that FDA has cleared its swallow-able sensor, which can be integrated into a pill to monitor medication adherence. The medical device, which the company refers to as an ingestible event marker (IEM), can monitor the timing of drug ingestion in the stomach and relay that information to a patch worn on the body. The patch also can track heart rate, activity levels, and sleep patterns, and relay such information, as well as information regarding drug compliance to caregivers via text message or e-mail. In addition, the device can be used to send text reminders to patients who forgot to take a pill on time. 

The company began working with FDA in 2008 to determine the product's regulatory pathway. The device was ultimately cleared as a de novo medical device via the 510(k) premarket approval process, designed for low-risk products without a predicate. 

The sensor is made of materials present in food such as copper, magnesium, and silicon (which is a trace mineral found in plants such as oats, barley, and rice). The device has no antenna or battery

In a statement, Eric Topol, professor of genomics at The Scripps Research Institute and author of "The Creative Destruction of Medicine," hailed the FDA decision as "a major milestone in digital medicine," adding that the device when used in conjunction with wirelss technology could "set a new standard for influencing medication adherence and significantly aid chronic disease management."  

The company's co-founder and chief medical officer, George Savage, MD, said in an interview with MD+DI that the technology has an array of potential applications. One of its advantages, he says, is that it can help bridge the gap in patient monitoring in inpatient and outpatient care settings. In a hospital settings, doctors generally know which medications their patients are taking. By contrast, in ambulatory settings, how well patients comply with pharmacotherapy regiments can be something of an unknown variable.

Proteus received a CE mark for the technology in August 2010, which cleared the technology's path to market in Europe. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

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