FDA Clears WellDoc DiabetesManager system
WellDoc has received FDA 510(k) clearance to market the WellDoc DiabetesManager system to healthcare providers and their adult patients with type 2 diabetes.
The FDA has cleared WellDoc’s mobile health system to offer automated clinical coaching and behavioral algorithms driven by real-time patient data, according to the Baltimore-based company. The software-based system allows healthcare professionals to configure parameters by utilizing mobile phones and the internet.
The DiabetesManager captures, stores and transmits blood glucose data and other diabetes self-management information, which is then analyzed by the company’s Automated Expert Analytics system that delivers educational and behavioral patient coaching and provider decision support, WellDoc said.
The FDA has cleared WellDoc’s mobile health system to offer automated clinical coaching and behavioral algorithms driven by real-time patient data, according to the Baltimore-based company. The software-based system allows healthcare professionals to configure parameters by utilizing mobile phones and the internet.
The DiabetesManager captures, stores and transmits blood glucose data and other diabetes self-management information, which is then analyzed by the company’s Automated Expert Analytics system that delivers educational and behavioral patient coaching and provider decision support, WellDoc said.