BASEL, Switzerland and MILAN, June 9, 2025 /PRNewswire/ — Newel Health, a European HealthTech company specialized in certified digital medical devices, announced today that Amicomed, its solution for hypertension management, has received CE certification as a Class IIa medical device under the European Medical Device Regulation (MDR 2017/745). This milestone positions Amicomed among the leading candidate digital therapies poised to reshape hypertension management in Europe.

Amicomed is a certified digital medical device by Newel Health that helps individuals manage their blood pressure day by day, directly from their smartphone. It offers personalized guidance, medication reminders, and lifestyle recommendations based on each person’s health profile and real-world data. Designed to fit seamlessly into daily life, Amicomed empowers users to take control of their hypertension between doctor visits. The solution supports long-term heart health and is trusted by patients, clinicians, and healthcare partners across Europe

Amicomed supports individuals in daily blood pressure self-management by offering personalized feedback based on real-world data and helping users between clinical visits. It captures structured blood pressure data and translates it into clinically meaningful insights for users and healthcare professionals. Key features include medication reminders to improve adherence and personalized lifestyle and dietary recommendations based on the user’s clinical profile.

In addition to its direct-to-consumer application, Amicomed can be deployed as a digital companion to antihypertensive therapies. It supports medication adherence and generates longitudinal behavioral insights. The solution has also been validated in population health programs for cardiovascular risk monitoring and chronic care optimization, as well as in digital insurance models focused on prevention and risk management. These use cases create pathways for adoption across pharmaceutical, insurance, and institutional ecosystems.

“We designed Amicomed to offer a digital therapy that fits into people’s everyday lives, supporting them, day by day, in managing hypertension,” said Ervin Ukaj, CEO of Newel Health. “The MDR certification confirms the strength of our platform and the reliability of our regulatory approach, enabling us to bring Amicomed to millions of individuals across Europe and to pursue scalable growth in partnership with public and private healthcare stakeholders.”

Certified. Scalable. Integration-ready.

Compatible with Apple Health, Google Fit, and major Bluetooth-enabled blood pressure monitors, Amicomed also accepts manual data entry, ensuring usability without connected devices. It provides users with weekly reports, personalized notifications, and structured summaries, while clinicians can monitor progress between visits.

“Amicomed transformed available cardiovascular knowledge into a robust, intuitive digital solution designed for large-scale adoption,” commented Professor Domenico Cianflone, member of the Scientific Advisory Board of Newel Health.