FDA approves Confidant mobile phone system for OTC sales
RESEARCH TRIANGLE PARK, N.C. The Food and Drug Administration has given Confidant market clearance for the over-the-counter sale of its chronic disease management product. Confidant is a manufacturer of mobile communication solutions for chronic disease management.
In May 2005, Confidant became the first company to receive clearance from the FDA for a mobile phone-based system to communicate with multiple home medical devices. This was followed by the October 2006 clearance, which included significant user interface improvements and the ability to work with a broader group of home medical devices.
Initially, the focus was on home diabetes management, with the system being capable of collecting data from a range of glucose meters, weight scales and blood pressure devices. With the OTC product, users can collect data from the same full range of off-the-shelf devices supported by the company’s prescription product. Objective and motivational feedback is returned directly to the user’s cell phone within seconds and automatic reminders help the user keep on track with routine monitoring.
Patient data can be accessed directly through the Confidant portal or by accessing Personal Health Record or Electronic Medical Record systems that are populated from the Confidant system.