FDA-Approval for Ingestible Sensors “Major Milestone”—Future of Home Health Care Monitoring?

The U.S. Food and Drug Administration (FDA) has approved an digital sensor that can be embedded in a pill and ingested to track health data from within the body, reports Medical News Today.

The ingestible sensor is about the size of a grain of sand and is made mostly of silicon.

The idea is that the data can be used not only by patients themselves, but also by caregivers and doctors 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 start of a era where digital medicine “shifts the care paradigm”.

[The pill] is part of an integrated system designed to give patients and their doctors “end-to-end personal health management”. 

This is important, because although 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 easy to monitor, and without information about precisely when patients are taking their medication, doctors can’t see if that is the problem, should the drug not work as it should.

The sensor passes through the body and relays information to a patch worn on the person’s skin, which senses the signal and records when the sensor was swallowed, says the article. This information is then passed along to a mobile phone application, and, with the patient’s consent, can be sent to doctors and caregivers. 

“The FDA validation represents a major milestone in digital medicine,” Eric Topol, a geneticist and cardiologist and professor of genomics at The Scripps Research Institute, is quoted as saying in the article. “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.”

Read the full article at Medical News Today

Written by Alyssa Gerace

Alyssa Gerace

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