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. The company was founded as a spin-off from Healthware Group and operates as a certified legal manufacturer under ISO 13485, with compliance to ISO 27001, HIPAA and the EU MDR framework, and alignment with FDA standards.

The product portfolio spans several therapeutic areas. Amicomed is a CE MDR Class IIa certified SaMD for hypertension management, and Rohkea holds the same certification for chronic musculoskeletal pain. Soturi, a SaMD for Parkinson's disease, is currently in an active clinical study. Underpinning these products 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 works through a dual business model: proprietary product development alongside certified manufacturing services for pharmaceutical and medtech partners. Its work touches the pharmaceutical, medical device and healthcare provider sectors, across cardiometabolic disease, neurology and chronic pain. The company operates within the European Union regulatory framework, with multiple CE-marked products in clinical deployment and an evidence-based approach built on real-world clinical data and active clinical studies.

Technical work at Newel Health covers artificial intelligence and machine learning, SaMD engineering, behavioural science, digital therapeutics, healthcare software engineering, and regulatory compliance and quality management systems.