MASSDEVICE ON CALL — The FDA handed Proteus Digital Health clearance for its novel ingestible sensor, passing the product through a new medical device category.
The sensor is swallowed in a pill and powered through contact with stomach fluids. The device communicates wirelessly with a patch on the skin, which collects metrics such as heart rate, body position and activity.
The patch then relays the data to a mobile phone application, which can make the information accessible to family, caregivers and clinicians, according to a press release.
"The FDA validation represents a major milestone in digital medicine," Scripps Research Institute genomics professor Dr. Eric Topol said in prepared remarks. "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."
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