Today marks a defining milestone for Newel Health and a significant step forward for the millions of people affected by hypertension worldwide. We are proud to announce that Amicomed, our clinically validated digital therapeutic for hypertension, has officially received CE certification as a Class IIa medical device under the European Medical Device Regulation (MDR 2017/745).
This is not simply a regulatory achievement. It represents formal recognition of Amicomed as a medical-grade digital intervention, held to the same standards of clinical efficacy, technical robustness, and patient safety as traditional medical devices. It also positions Amicomed for reimbursement and clinical adoption across health systems in Europe and beyond.
Behind this certification stands the dedication of the entire Newel Health team. Engineers, clinical scientists, product developers, and regulatory specialists have worked in close coordination to deliver a rigorously developed solution that meets both the complexity of the condition and the realities of daily life. This milestone marks the transition from innovation to implementation. Amicomed is now fully cleared for prescription, integration into chronic care pathways, and wide-scale deployment.
The Global Burden of Hypertension: A Crisis in Need of Scalable Solutions
Hypertension, or high blood pressure, affects more than 1.28 billion adults globally and causes approximately 10 million deaths each year. It remains the leading preventable cause of cardiovascular disease, yet over 700 million peoplewith hypertension are undiagnosed or inadequately treated. Although effective therapies are available, fewer than one in five individuals with hypertension achieve adequate control. The primary challenge is not a lack of treatment options, but rather the difficulty of maintaining daily self-management routines, monitoring blood pressure consistently, adhering to medications, and sustaining lifestyle changes. These challenges are compounded by limited access to care and insufficient follow-up.
This is where Amicomed delivers unique and measurable value.
Amicomed: A Clinically Validated Digital Companion for Hypertension Management
Amicomed empowers individuals to manage their blood pressure through their smartphone, transforming clinical guidance into day-to-day support. It provides personalized recommendations, medication reminders, and lifestyle coaching tailored to each person’s health profile. Users can integrate connected devices or manually input data, gaining real-time insights that are both actionable and clinically grounded. For healthcare professionals, Amicomed acts as a digital extension of care, improving adherence and continuity between visits.
The solution is built on Newel Health’s proprietary H.Core platform, which combines clinical algorithms, artificial intelligence, and behavioral science to deliver therapeutic precision at scale. The platform ensures clinical consistency, localization, and seamless integration into diverse care models. Amicomed has been designed to meet the highest international standards, making it well suited for wide adoption across different health systems and populations.
From Certification to Global Reach: Strategic Market Deployment
With regulatory approval secured, Amicomed is actively launching across three strategic channels to maximize accessibility, adoption, and long-term health outcomes.
Direct to Consumer (B2C): Amicomed is now available in key European markets as a stand-alone mobile application. It offers a user-centric experience that enables individuals to engage with their condition through personalized, real-time hypertension management. Uptake has been particularly strong among digitally engaged users seeking structured, evidence-based tools to complement or substitute traditional care.
Health System and Payer Integration: Through collaborations with public and private insurers, Amicomed is being integrated into chronic disease programs and included in benefit design. Clinicians and care teams are prescribing the solution to support long-term management of hypertension, enhance patient engagement, and improve clinical outcomes. These deployments also generate valuable real-world evidence to support future scale-up.
Global Expansion in Underserved Regions: Amicomed is being introduced in emerging markets through partnerships with ministries of health, NGOs, and international development agencies. These efforts aim to address the gap in cardiovascular care in regions where specialized providers and consistent follow-up are scarce. Amicomed’s digital architecture allows for low-barrier deployment and culturally adapted care pathways.
Looking Ahead
This certification marks the beginning of a new chapter for Newel Health. Amicomed is not only a clinically proven product but also a platform that reimagines how chronic conditions can be managed through technology. It combines science, design, and scalability to make hypertension care more personalized, more accessible, and more effective.
We are excited about the road ahead and remain committed to ensuring that Amicomed reaches the individuals and systems that need it most. The future of hypertension management is no longer a concept. It is here, and it is measurable, inclusive, and ready to scale.
