AI-driven digital medical devices for chronic disease. Built to the standard the problem deserves.
Newel Health develops and manufactures certified Software as Medical Devices (SaMDs) combining AI, behavioural science, and real-world data across cardiometabolic disease, Parkinson's, and chronic pain and partners with pharmaceutical companies and healthcare systems to bring Digital Medical Devices safely and credibly to market.
Why we exist
Chronic disease is continuous.
Care is not.
74% of global deaths are driven by noncommunicable diseases. Conditions that require daily management, behavioural change, and continuous clinical support, delivered through a system built for acute, episodic care.
The gap between what patients need and what the system provides is not a funding problem. It is an infrastructure problem. And it is the problem Newel Health was built to close.
We develop AI-driven digital medical devices that extend care into the 365 days between clinical encounters, certified, clinically validated, and designed to work in the real world.
74%
of global deaths driven by NCDs
3–4
clinical visits per year on average
365
days of largely unsupported self-management
Therapeutic areas
Three therapeutic areas. One standard.
Evidence at every stage.
We focus where digital can deliver measurable, lasting clinical value.
1.28B
people with hypertension
Cardiometabolic
We build digital interventions that extend clinical care into daily life, reducing blood pressure, improving adherence, and cutting cardiovascular risk where it is most preventable.
Explore Cardiometabolic →
12M
people with Parkinson's today
Neurology
We are building the continuous monitoring and AI-guided dose optimisation infrastructure that episodic clinic visits cannot provide.
Explore Neurology →
619M
people with chronic low back pain
Pain
We deliver cognitive behavioural therapy through certified VR, at home, at scale, closing the access gap that medication cannot.
Explore Pain →How we work
A portfolio company and a certified manufacturer. AI built for regulated medicine powers both.
- 1
We build our own products.
Two CE MDR Class IIa certified products are in clinical deployment today: Amicomed for hypertension and Rohkea™ for chronic musculoskeletal pain. A third, Soturi, is in active clinical study for Parkinson's disease.
- 2
We build for partners.
As a certified legal manufacturer of SaMD, we co-develop digital endpoints, companion therapeutics, and patient support programs, taking full regulatory accountability from design control to post-market surveillance.
- 3
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 on real-world clinical data. Every product built on H.Core inherits compliance evidence and AI capability from the ground up, which is how we move fast without cutting corners.
Our certifications
News
Inside the future of care.
Elevating the Patient Voice: Why Newel Health is Heading to the European Patients’ Forum Congress
Closing Frontiers Health: A Strategic Partnership and the Future of Connected Care
Scaling Innovation in Cardiometabolic Health: Highlights from the Frontiers Health Berlin Panel
Ready to build in digital health? We are already doing it.
Whether you want to license a certified product, co-develop a SaMD, or simply understand what is possible. The best next step is a conversation.