Our Story
Built for the future of continuous care
Newel Health is a digital medical device company focused on chronic disease. Born as a spin off from Healthware Group, Newel combines deep digital health roots with a clear mission: to make care more continuous, personal, and effective through regulated, AI enabled digital medical devices. Today, the company operates with certified products, a growing pipeline, and a legal manufacturer model built to scale with partners.
The problem
Chronic disease is lived every day. Care still is not.
Most patients manage their condition between just a few doctor visits each year. The rest of the time, they are on their own. That gap drives poor adherence, worse outcomes, and rising costs. Newel Health was built to close that gap with digital medical devices that support patients in everyday life, not only in clinical moments.
74%
of global deaths driven by NCDs
3–4
clinical visits per year on average
365
days of largely unsupported self-management
Our founding
Built on heritage. Positioned for scale.
Newel Health unites the legacy of Healthware Group with the ambition, discipline, and execution of a company built to lead in digital medicine. Today, it stands on a strong foundation of certified legal manufacturing capability, a proprietary platform, strategic partnerships, CE marked products, and a growing pipeline across high impact conditions.
This is not a company proving a concept. It is a company building category leadership.
That is why our model stands on four pillars
Quality Management System and Certifications
Trust is the foundation of everything we build. Our quality systems and certifications provide the structure needed to develop and scale digital medical devices with the discipline, safety, and reliability that healthcare demands.
Behavioral Science
Health outcomes are shaped not only by treatment, but by everyday behavior. We embed behavioral science into our solutions to help people build healthier habits, stay engaged, and sustain change over time.
AI with purpose
We use AI to make care more adaptive, more timely, and more relevant. Not as a feature added for effect, but as a foundational capability that helps personalize support, strengthen engagement, and improve the care experience continuously.
End to end expertise
From strategy and design to development, regulatory execution, launch, and commercialization, we work across the full lifecycle of digital medical devices. This allows us to move from idea to impact with consistency, depth, and real world focus.
Leading Newel Health through scale
Leading Newel Health through scale
Ervin Ukaj joined Newel Health as CEO in 2024 and is leading the company through a phase of accelerating growth. He brings international experience across digital health, clinical innovation, and growth strategy, including senior roles at Novartis and earlier entrepreneurial experience building and scaling science based digital health businesses across Canada, the United States, Europe, and China. At Newel Health, he is focused on strengthening commercial execution, expanding strategic partnerships, and translating the company's scientific and regulatory strengths into broader market impact.
Ervin Ukaj
CEO, Newel Health
How we work
One company. Two engines for growth.
Newel Health develops its own AI enabled digital medical devices in high impact therapeutic areas including cardiometabolic disease, neuroscience, and chronic pain. At the same time, as a certified SaMD legal manufacturer, it co develops compliant digital solutions with pharma and medtech partners. At the center of both is h.Core, the proprietary platform that brings together AI, personalization, and regulatory execution to power development at scale.
We build our own products.
Across three therapeutic areas, cardiometabolic disease, Parkinson's, and chronic pain, we develop, certify, and commercialise our own digital medical devices. These are CE-marked, clinically validated, and available for pharma and health system partners to license, brand, and deploy.
We build for partners.
For pharmaceutical and medtech companies that want to integrate digital into their pipeline, we act as a certified legal manufacturer. We co-develop custom SaMDs including digital endpoints, companion therapeutics, and patient support programs, and take on full regulatory responsibility from design control to post-market surveillance.
H.Core makes both possible.
Our proprietary AI platform integrates our quality management system, a library of pre-qualified clinical modules, a behavioural science engine, and an AI/ML layer trained continuously on real-world patient data. Every product we build inherits compliance and clinical intelligence from the ground up. Speed doesn't come at the cost of rigor. It comes because of it.
Learn more about H.Core →Building the infrastructure for continuous, AI-driven care
Newel Health is building a new standard for chronic care, grounded in science, enabled by technology, and designed for real world adoption. With a strong foundation, credible heritage, and growing market traction, the company is positioned to shape the next generation of digital medicine.
Born as a spin off from Healthware Group, Newel combines deep digital health roots with a clear mission: to make care more continuous, personal, and effective through regulated, AI enabled digital medical devices.
Our cities
Leadership
A team built for execution
Newel Health is led by a team with deep expertise across digital health, clinical research, product design, behavioral science, and regulatory strategy. Newel has the leadership, the capabilities, and the operating model to lead in digital medicine.
Ervin Ukaj
CEO
Pier Paolo Iagulli
COO & Co-Founder
Raffaele Aulisio
Head of Engineering
Silja-Riin Voolma, PhD
Head of Behavioral Science
Advisors
Roberto Ascione
Chairman
Christopher Eccleston
Scientific Advisor, Pain & Behavioral Medicine
Mariateresa Pellecchia
Scientific Advisor, Neuroscience
Sammeli Likkanen
Advisor in Business Development, Pain and Parkinson
Gerry Chillé
Advisor in Business Development
We're building the AI infrastructure for digital medicine.
Whether you're a pharma partner looking to bring a digital therapeutic to market, an investor evaluating the digital health landscape, or a health system exploring new ways to support patients, we'd love to talk.