A medical sensor on your wrist or chest? Forget about it. Now you can ingest one.
The U.S. Food and Drug Administration (FDA) has approved an ingestible sensor from Proteus Digital Health for marketing as a medical device, according to a company press release. The small sensor works by being inserted into an inert pill or other ingested product and then swallowed.
Once inside the body, the sensor uses a patient’s stomach fluid to power it. It can then communicate with a patch worn on the skin. That information also can be retrieved by doctors and caregivers to monitor the patient’s health, with the patient’s consent.
Proteus, based on Redwood City, CA, has been working with FDA since 2008 to determine the regulatory pathway for this sensor, which falls in a new category of medical device and patient care. The sensor’s application with the FDA was processed with the provisions of the Federal Food, Drug and Cosmetic Act for low-risk devices that have no precedent in the market.
“The FDA validation represents a major milestone in digital medicine,” says Dr. Eric Topol, professor of genomics at The Scripps Research Institute and author of a publication that discusses how digital devices in medicine will create better healthcare. “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.”
Other physiological and behavioral traits that the ingestible medical device can measure include heart rate, body position, and activity. The patch relays information to a mobile phone application. With the information obtained from the sensor, caregivers and clinicians will have more data to help individuals develop and sustain healthy habits, and families to make better health choices, the company says.
Source: “Proteus Digital Health Announces FDA Clearance of Ingestible Sensor,” Proteus Digital Health press release, 7/30/12
Source: “Powered by You,” Proteus Digital Health
Dale McGeehon has been a journalist and editor for more than 25 years, covering chemical regulation and testing for Pesticides and Toxic Chemical News and innovations in material sciences for the National Technology Transfer Center. His writing credits include Omni and College Park magazines and The New York Times.