Newel Health develops and manufactures certified Software as Medical Devices for chronic disease management, combining AI, behavioural science and real-world clinical data.
Newel Health is a digital medical device company that develops and manufactures certified Software as Medical Devices (SaMDs) for chronic disease management. Its products combine artificial intelligence, behavioural science and real-world clinical data. Two devices are CE MDR Class IIa certified and in clinical deployment: Amicomed, for hypertension management, and Rohkea, for chronic musculoskeletal pain. A third, Soturi, is a SaMD for Parkinson's disease currently in 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 for regulated medical device development. The company's technical work spans artificial intelligence, machine learning, behavioural science, digital therapeutics and the analysis of real-world clinical data, applied across cardiometabolic disease, neurology and chronic pain.
Newel Health operates as an ISO 13485-certified legal manufacturer and works to EU MDR, FDA-aligned standards, ISO 27001 and HIPAA requirements. It is a spin-off from Healthware Group and also provides certified manufacturing services to pharmaceutical and medtech partners, serving clients across digital health, pharma, medtech and healthcare systems.
