The FDA has approved an ingestible sensor for marketing as a medical device, according to the manufacturer, Proteus Digital Health Inc.
The sensor, which can be part of an inert pill or other ingested products, consists of an integrated circuit in the center, surrounded by a friable disc. The integrated circuit, which measures 1 mm x 1 mm x 0.45 mm, is coated with a copper salt on one side and magnesium on the other.
Once ingested, the device communicates the identity and timing of ingestion to a patch worn on the skin. The patch also wirelessly relays additional physiologic information — heart rate, body position and activity — to a mobile phone application. This data, with patient consent, is then available to caregivers and clinicians.
Proteus announced recently that the “digitized pills” were processed as low-risk devices through the Federal Food, Drug and Cosmetic Act.
“The levels of silicon, copper, magnesium, and other minerals present in the sensor are far below levels commonly present in the diet,” according to a Proteus press release.
“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,” said George M. Savage, MD, co-founder and chief medical officer at Proteus, based in Redwood City, Calif.
According to a technical document on the company’s website, the friable disc is 5 mm in diameter and 200 mcm in thickness, made of cellulose-based pharmaceutical excipient materials, weighing approximately 5 mg.
Before ingestion, the sensor is considered inert. After ingestion, stomach fluid and surrounding tissue provide the sensor’s electrolyte. The copper salt and magnesium act as cathode and anode, respectively. The combined electrochemical redox reaction produces a voltage of 1 V to 2 V across the integrated circuit, which is stored on the integrated circuit using an on-chip capacitor and diode.
“The FDA validation represents a major milestone in digital medicine,” Eric Topol, MD, professor of genomics at The Scripps Research Institute, said in the press release.
Topol, who is not affiliated with Proteus, said “directly digitizing pills, for the first time … may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management.”
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