FDA Grants Approval to Mobile Phone App for Managing Diabetes

TOPIC ALERT:

FDA has granted 510(k) clearance to the health software firm WellDoc to begin marketing its DiabetesManager System, a mobile phone application designed to help patients and health care providers manage Type 2 diabetes, The Gazette reports.

How It Works

The application collects real-time patient data on blood-sugar levels and other health indicators (Rand, The Gazette, 8/2). The system then runs the data through a program that uses automated clinical coaching and behavioral algorithms to identify trends and generate relevant educational materials (Dolan, Mobihealthnews, 8/2).

WellDoc's application also offers nutritional recommendations and other guidance on disease management.

Next Steps

WellDoc said it plans to begin marketing the product in early 2011.

The company said it eventually might apply the technology to the management of other chronic conditions such as asthma, cancer and heart disease (The Gazette, 8/2).


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