Amicomed by Newel Health obtains EU MDR certification as a digital medical device for hypertension management

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 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.

Amicomed will be distributed through a multi-channel strategy that includes direct-to-consumer, health insurance partners, digital pharmacies, corporate wellness programs, and public healthcare systems. Strategic discussions and pilot programs are currently underway across several European countries.

Powered by H.Core: AI and personalization at the center

Amicomed is built on H.Core, Newel Health's proprietary platform that integrates clinical logic, behavioral science, and real-world data to deliver personalized digital therapeutic pathways. H.Core uses predictive models powered by artificial intelligence to improve behavioral segmentation, sustain engagement, and adapt interventions to the individual profile. The platform ensures clinical consistency, scalability, and alignment with international standards for safety, performance, and software quality.

About Newel Health

Newel Health is a European HealthTech company developing certified digital medical devices that combine clinical science, behavioral psychology, and intelligent technology. With teams in Milan, Basel, Salerno and Tallinn, the company creates software-based therapeutics that address chronic diseases where user behavior and real-world data are central to clinical outcomes.

At Newel, user experience is part of the clinical model. Every solution is designed to be intuitive, engaging, and scalable. Through its proprietary platform H.Core, Newel enables continuous product optimization informed by behavioral analytics and longitudinal health signals.

Newel operates a full-stack infrastructure for the development, certification, and

commercialization of software as a medical device across global markets, including the European Union, the United States, and China. The company works with pharmaceutical leaders, health insurers, and public health systems to co-develop and scale regulated therapeutics that are clinically validated, commercially viable, and globally deployable.

Newel's portfolio includes certified therapeutics for hypertension (Amicomed) and chronic pain (Rohkea), with additional programs in Parkinson's disease, metabolic health, and cardiovascular prevention advancing through development.

For more information: www.newel.health
Media contact: media@newel.health

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