WellDoc®, a healthcare company that develops technology solutions to improve chronic disease management outcomes and reduce healthcare costs, today announced that it has received United States Food and Drug Administration (FDA) 510(k) clearance to market the WellDoc DiabetesManager® System to healthcare providers and their adult patients with type 2 diabetes.
“With the WellDoc DiabetesManager System, we provide the medical community with decision-support tools that can help doctors and patients work together to manage diabetes more effectively”
People with diabetes face daily, ever-present challenges in the self-management of their disease. The FDA has cleared WellDoc's revolutionary mobile health (mHealth) System to offer automated clinical coaching and behavioral algorithms driven by real-time patient data. The software-based System supports patients and enables healthcare professionals to configure specific parameters and extend their care beyond traditional office visits by utilizing mobile phones and the Internet.
"With type 2 diabetes reaching epidemic rates and limited time for care, healthcare providers need new tools to more efficiently engage their patients between and during office visits," said Richard Bergenstal, M.D., executive director of the International Diabetes Center at Park Nicollet and president of the American Diabetes Association (ADA). "WellDoc's System addresses this need by delivering real-time, evidence-based education and behavioral coaching. This enhanced engagement and communication is intended to enable providers to support positive patient behavior and improved health."
The WellDoc System addresses a pressing need for innovative approaches to diabetes treatment. In development for more than five years, the DiabetesManager System supports medication adherence and securely provides for the capture, storage, and real-time transmission of blood glucose data and other diabetes self-management information. This information is then analyzed by the company's proprietary Automated Expert Analytics System™, which identifies trends and then delivers relevant educational and behavioral patient coaching and provider decision support, thus enabling effective lifestyle and medication adjustments.
"With the WellDoc DiabetesManager System, we provide the medical community with decision-support tools that can help doctors and patients work together to manage diabetes more effectively," said Suzanne Sysko Clough, M.D., founder and chief medical officer of WellDoc. "WellDoc products are rigorously developed by our clinical staff using evidence-based guidelines and then tested for their impact on health outcomes. Patients and providers expect a certain quality level from all medical devices, including mHealth solutions, so obtaining FDA clearance is a critical milestone."
The company intends to commercially launch the WellDoc DiabetesManager System in early 2011, and will be an exhibitor in the inaugural Mobile Health Pavilion at the annual meeting of the American Association of Diabetes Educators (AADE), August 4-7 in San Antonio.
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