This week the FDA approved the first “smart pill” that senses when it’s been taken, sends data to wearable patch. Manufactured by Proteus Digital Health, the ingestible sensor which is about 1 square millimeter and made out of silicon and ingredients found in food, can be embedded in a pill and swallowed. Fluids in the stomach act as a power source to activate the sensor, which communicates a signal to the wearable patch that marks the timing of ingestion. The wearable patch is battery-operated and can also measure heart rate, temperature and activity but must be changed every seven days.
Data collected by the sensors is relayed to a mobile phone application where it can be accessed by caregivers and clinicians. The system was tested in many different therapeutic areas including tuberculosis, mental health, heart failure, hypertension and diabetes.
A number of healthcare organizations and pharmaceutical and medical device companies have invested in the technology and Proteus has worked collaboratively with the FDA since 2008 to determine the regulatory pathway for this innovation, which represents a new category of medical device and patient care. The application was ultimately processed in accordance with the de novo provisions of the Federal Food, Drug and Cosmetic Act for low-risk devices that have no predicate on the market.
It is believed that directly digitizing pills in conjunction with a wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management.