Another Advance in Digital Medicine
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.