WellDoc receives FDA approval for DiabetesManager System

BALTIMORE WellDoc, a healthcare company that develops technology solutions to improve chronic disease management outcomes and reduce healthcare costs, on Monday announced that it has received Food and Drug Administration 510(k) clearance to market the WellDoc DiabetesManager System to healthcare providers and their adult patients with Type 2 diabetes.

BALTIMORE WellDoc, a healthcare company that develops technology solutions to improve chronic disease management outcomes and reduce healthcare costs, on Monday announced that it has received Food and Drug Administration 510(k) clearance to market the WellDoc DiabetesManager System to healthcare providers and their adult patients with Type 2 diabetes.

“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,” stated Richard Bergenstal, executive director of the International Diabetes Center at Park Nicollet and president of the American Diabetes Association. “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.”

WellDoc’s mobile health system provides automated clinical coaching and behavioral algorithms driven by real-time patient data. The 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.

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, 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, August 4-7 in San Antonio.