US-based digital health company Welldoc has received CE mark for its BlueStar mobile app, as a Class 2a medical device under the European Union Medical Device Regulation (EU-MDR).

BlueStar is an FDA-approved digital health solution that guides individuals through the complicated journey of living with diabetes.

The mobile app enables patients living with diabetes to self-manage their care while improving connections with their healthcare team.

The CE mark approval allows the digital health company and its strategic partners to advance digital health solutions in the EU, addressing growing chronic condition needs.

The EU approval builds upon Welldoc’s existing 11 FDA approvals for type 1 and type 2 diabetes management capabilities, including advanced insulin dosing calculators.

Welldoc president and CEO Kevin McRaith said: “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 leverages personalised, AI-driven digital coaching and insights to guide people living with diabetes through their complicated journey of care.

Its broader 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 the EU safety, performance and quality standards for Class IIa medical devices.

Furthermore, the company has completed an assessment of the quality management system, technical documentation and clinical benefits by an independent notified body.

Welldoc is engaged in integrating personalised, real-time and actionable insights into the lives of individuals living with cardiometabolic conditions to enable improved health and outcomes.

Its digital health platform provides support across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, with integrated mental wellbeing and sleep support.