Approved sensor can reveal whether medicine is taken

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The U.S. Food & Drug Administration has given marketing approval to an ingestible pill that monitors medication adherence. Proteus Digital Health Inc. makes the Ingestion Event Marker (IEM), which was approved for use in Europe in 2011.

The IEM can transmit information about the patient to medical professionals.

It's “an important milestone,” said George M. Savage, M.D., co-founder and chief medical officer at the firm. “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.”

Savage insists the sensor is not going to punish patients for missing their meds.

“The rationale for doing this is not to scold patients for being imperfect,” Savage said. “Not one of us is perfect. That's the point.”

The sensor, which the company describes as about the size of a grain of sand, can be buried within a pill. Upon ingestion, it sends signals to a petite, water-resistant patch worn by the patient. Once the patch receives its signal, information is wirelessly uploaded to anything that can reach the Internet, including mobile phones, laptops and tablets. A password keeps the information private, and interested parties can log in and see how a patient's actual daily medication habits match up with the prescribed ones.

A clinician or caregiver can see just how much a patient is sticking with a regimen. Savage said this information could provide a critical talking point for doctors, which is, “Why haven't you been taking your medications?”

The information, which the firm describes as a digital health feedback system, provides a valuable opportunity for follow-through. It could turn out that the right medication has been prescribed but is ineffective because of inconsistent use. Or, if a new dose shows a higher adherence rate, but a patient still feels poorly or isn't improving, the data could signal a problem with medication choice.
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