Confidant International LLC, a Durham, N.C.-based developer of mobile communication solutions for chronic disease management, has received market clearance from the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) sales of its chronic disease management product.
Confidant says in May 2005, it 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 user interface improvements and the ability to work with a broader group of home medical devices. According to the company, with an initial focus on home diabetes management, the system is 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 range of off-the-shelf devices supported by the company’s prescription product. Objective and motivational feedback is returned to the user’s cell phone and automatic reminders help the user keep on track with routine monitoring, the company claims.
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