Newel Health

Newel Health is a digital medical device company that develops and manufactures certified Software as a Medical Devices (SaMDs) for chronic disease management. Its products combine artificial intelligence, behavioural science and real-world clinical data, and the company operates as an ISO 13485-certified legal manufacturer. It was founded as a spin-off from Healthware Group and works to EU MDR and FDA-aligned standards, including ISO 27001 and HIPAA compliance, with activity in the European Union and the United States.

Two of its products hold CE MDR Class IIa certification and are in clinical deployment: Amicomed, for hypertension management, and Rohkea, for chronic musculoskeletal pain. Soturi, a SaMD for Parkinson's disease, is currently in an active clinical study. These address cardiometabolic disease, chronic pain and neurology, alongside work with pharmaceutical, medtech and healthcare-system partners.

Underlying the product pipeline is H.Core, a proprietary AI platform that integrates regulatory compliance, quality management systems, pre-qualified clinical modules and machine-learning capabilities designed for regulated medical device development. Newel Health runs a dual business model: proprietary product development alongside certified manufacturing services for pharmaceutical and medical device organisations.

Technical work spans artificial intelligence, machine learning, behavioural science, real-world clinical data, digital therapeutics, regulatory compliance engineering and quality management systems. Engineering culture is shaped by the requirements of a certified legal manufacturer, with an emphasis on safety, credibility and compliance in bringing digital medical devices to market.