COLUMBIA, Md.--(BUSINESS WIRE)--Welldoc, a leading digital health company specializing in cardiometabolic health, today announced that its flagship BlueStar® mobile app has received CE mark certification as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). This significant achievement allows Welldoc to apply the CE mark to their medical device software. It also enables the company and their strategic partners to advance digital health solutions in the EU, addressing chronic condition needs that are rising globally. This announcement builds upon Welldoc's existing 11 FDA clearances for type 1 and type 2 diabetes management capabilities, including advanced insulin dosing calculators. This milestone underscores the company’s continued commitment to the highest standards of quality, while also demonstrating extensive leadership in AI-based digital health solutions.
“We are thrilled to receive the CE mark certification,” said Kevin McRaith, President and CEO at Welldoc. "This milestone is integral to our collaboration with strategic partners in life sciences, as they expand access to innovative digital health solutions and empower a broader population in the EU to better manage their chronic conditions effectively."
Welldoc’s regulated digital health solution guides individuals through the complicated journey of living with diabetes using personalized, AI-driven digital coaching and insights. The broader Welldoc platform provides additional support for multiple cardiometabolic conditions, including weight management and hypertension.
The CE mark certification indicates that Welldoc’s digital health solution meets stringent safety, performance and quality standards established by the EU for Class IIa medical devices. This was demonstrated by a comprehensive assessment of the company's quality management system, technical documentation and clinical benefits by an independent notified body.
About Welldoc
Welldoc®, a digital health leader revolutionizing cardiometabolic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with cardiometabolic conditions, enabling improved health and outcomes. Welldoc’s comprehensive digital health platform provides multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, with integrated mental wellbeing and sleep support. Welldoc’s flagship product, BlueStar®, is an FDA-cleared digital health solution that guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. These capabilities are now integrated into the Welldoc platform, providing comprehensive and flexible support across conditions. Welldoc partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs. The company has achieved 11 510(k) clearances for diabetes functionality within its digital health platform, and an IP portfolio of 43 patents for its advanced AI and first-in-class tech. With over 75 clinical publications, Welldoc has also built an extensive library of clinical research, including 17 publications focused on the value of combining CGM with AI-powered digital health solutions. For more information, visit www.welldoc.com. Follow us on LinkedIn and Twitter.
