Proteus gains de novo FDA clearance for ingestible biomedical sensor

By: Neil Versel | Jul 30, 2012        

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Proteus Biomedical's Raisin system

Proteus Biomedical's Raisin system

Proteus Digital Health, formerly known as Proteus Biomedical, has become the first company to receive Food and Drug Administration clearance for an ingestible biomedical sensor that monitors medication adherence.

The FDA granted 510(k) premarket approval to the Proteus Ingestible Event Marker (IEM) as a de novo medical device, meaning that there was no similar product on the market, four years after Redwood City, Calif.-based Proteus first sought clearance. A related wireless sensor patch worn on the skin gained FDA clearance in 2010 because there were predicate devices previously cleared by the FDA.

The IEM sensor, which can be embedded into a pill, is activated by stomach fluid, then transmits a signal through the body to the skin patch, indicating that a patient has ingested medication. The patch also measures patient vitals and body position, and wirelessly sends all of the data to a Proteus smartphone app.

Both the patch and the IEM secured the CE Mark in Europe in 2010, and Proteus this year inked a deal with British pharmacy chain Lloydspharmacy to sell the monitoring system in the UK and other European countries. The product will hit the European market in September, according to Arna Ionescu, director of user experience at Proteus.

The American regulatory process was more drawn-out, as Proteus first sought FDA clearance for both the IEM and the patch in 2008. “We worked very closely with the FDA to [find a regulatory pathway to] get this through,” an elated Ionescu told MobiHealthNews Thursday in Boston at the 4th annual World Congress Leadership Summit on mHealth. “It took a lot of creativity to get this through.”

A year ago, Proteus secured a patent for the ingestible sensor, which some have dubbed a “chip in a pill.”

In a Proteus press release issued Monday, Dr. Eric Topol, director of the Scripps Translational Science Institute in La Jolla, Calif., and author of “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare,” called the FDA clearance ” a major milestone in digital medicine,” According to Topol, “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.”

Ionescu said that the company is still developing its U.S. sales plans and would have more information later. All along, Proteus has been busy lining up investors.

In May, Proteus disclosed that it had raised about $17.5 million in a round of funding it hopes will eventually top $50 million. In 2010 the company received a $24 million investment from pharmaceutical maker Novartis.

Proteus also quietly raised about $25 million in late 2009.