Digital health company Welldoc has secured CE mark certification for its BlueStar mobile app, unlocking the advancement of its solutions in Europe.
The app has been certified as a Class IIa medical device under the EU Medical Device Regulation.
This certification allows Welldoc and its strategic partners to expand their digital health solutions within the EU, targeting chronic condition needs that are increasing globally.
The CE mark certification for BlueStar is a testament to Welldoc's adherence to the EU's safety, performance, and quality standards for medical devices.
It also complements the company's 11 clearances for type 1 and Type 2 diabetes management from the US Food and Drug Administration (FDA), which include advanced insulin dosing calculators.
BlueStar provides personalised, AI-driven digital coaching and insights to support individuals managing diabetes.
The broader Welldoc platform also offers support for various cardiometabolic conditions, such as hypertension and weight management.
Welldoc president and CEO Kevin McRaith said: “We are thrilled to receive the CE mark certification. 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.”
The certification process involved a thorough assessment of Welldoc's quality management system, technical documentation, and clinical benefits by an independent notified body.
Last March, Astellas Pharma and Roche Diabetes Care Japan entered an agreement to develop and commercialise the latter’s Accu-Chek Guide Me blood glucose monitoring system as a combined medical product with BlueStar.
The BlueStar solution is FDA-approved for usage by adults and is available in Canada and the US.
In August 2023, WellDoc received an 11th FDA 510(k) clearance for BlueStar.
A continuous glucose monitoring-informed bolus insulin dose calculator has been added to the device.
