Certification unlocks advancement of Welldoc’s digital health solutions in Europe, powering expanded access to cardiometabolic-focused digital health
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.
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