FDA Approves Ingestible Sensor That Tracks Health From The Inside

Featured ArticleMain Category: Medical Devices / DiagnosticsAlso Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug ApprovalsArticle Date: 02 Aug 2012 – 5:00 PDT

Current ratings for:FDA Approves Ingestible Sensor That Tracks Health From The Inside

Article opinions: 4 postsThe US Food and Drug Administration has approved an ingestible digital sensor that can be swallowed in a pill to track health data from inside the body. The idea is that the data can be used not only by patients themselves, but also by caregivers and physicians to individualize their care.

The ingestible sensor, formerly known as the Ingestion Event Marker or IEM, is already approved for use in Europe.

It is the first “digital pill” to receive FDA approval, in a move that its maker Proteus Digital Health, whose headquarters are in Redwood City, California, sees as the begin of a era where digital medicine “shifts the care paradigm”.

On Monday, George Savage, co-founder and chief medical officer at Proteus Digital Health, told the press:

“We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe.”

“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,” he added.

The ingestible sensor, which is about the size of a grain of sand and made mostly of silicon, is part of an integrated system designed to give patients and their physicians “end-to-end personal health management”.

Embedded in a pill or tablet, the device can help keep an eye on whether patients are taking their medications at the prescribed time and rate.

This is important, because even though the effectiveness and safety of drugs are established in clinical trials, those tend to follow well-controlled conditions, with patients taking their drugs at the prescribed rates in the right quantitities.

But at home, adherence to prescribed regimens may not be so simple to monitor, and without information about precisely when patients are taking their medication, physicians cannot see if that is the problem, should the drug not work as it should.

The sensor does not contain a battery, it works like a “potato battery” that kids make in science lessons at school. It has two conductive materials, one on either side. When these get wet in the stomach, they power the sensor for a short amount of time.

So once it comes into contact with stomach fluid, the sensor powers up, and “communicates a unique signal that determines identity and timing of ingestion”, states Proteus.

The ingestible sensor passes through the body in much the same way as high-fiber food, according to information on the company’s website.

The signal that it sends from the stomach travels through the patient’s body to a patch worn on the skin. The patch contains technology that senses the signal and records the exact time the ingestible sensor was swallowed.

The patch can then send this information to a mobile phone application, and with the consent of the patient, be passed on to physicians and caregivers, so they can provide better quality care.

Proteus states its integrated “feedback” system is also designed to collect a range of other measurements, such as for heart rate, body position and activity.

Eric Topol, geneticist and cardiologist, is a professor of genomics at The Scripps Research Institute and wrote a book called “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare” where, among other things, he states technology that gives physicians a continuously updated picture of what is happening with each patient, will help them provide better, individualized care.

“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.”

Written by Catharine Paddock PhDCopyright: Medical News TodayNot to be reproduced without permission of Medical News Today

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Visitor Opinions (latest shown first)Blood sugar monitoringposted by Ronald on 2 Aug 2012 at 6:56 am

This technology might be applied to the need to monitor blood sugar. Rather than using lancets, the data could be acquired by the patch for transmission. Other blood data might also apply.

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How valuable?posted by Jerry on 2 Aug 2012 at 6:32 am

Did I miss something? It doesn’t take high-fiber food long to pass through the body. How many dosages of medicine will this device have time to monitor before it is expelled. Also, kudos to the company for their “end to end” quote. And, the cost?

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Perfect name for the companyposted by David on 2 Aug 2012 at 6:27 am

Proteus. What a Fantastic Voyage the new digital pill must have. I always love the sci-fi references in the current tech innovations.

If they now could explain how Ms. Welch could breath in that skin tight wet suit?

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Weird….posted by J.N. on 2 Aug 2012 at 5:49 am

Sounds like a bad idea to me…. Basically this will track anything you put into your body. Then it will let others know exactly what you are eating, drinking, even smoking. How long until they begin selling that info to advertising companies without our knowledge and certainly without compensating us. If an advertising company wants to know what I eat, drink, watch and listen to, they need to PAY ME.

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