Newel Health

Newel Health is a digital medical device company that develops and manufactures certified Software as Medical Devices (SaMDs) for chronic disease management. The company operates as an ISO 13485-certified legal manufacturer, with multiple CE-marked products already in clinical deployment across cardiometabolic disease, neurology, and chronic pain.

The company's product portfolio includes Amicomed and Rohkea, both CE MDR Class IIa certified devices targeting hypertension and chronic musculoskeletal pain respectively. Soturi, a device for Parkinson's disease, is currently in active clinical study. These products are built on the proprietary H.Core AI platform, which integrates regulatory compliance, quality management systems, pre-qualified clinical modules, and machine learning capabilities for regulated medical device development.

Newel Health's technical work spans artificial intelligence, machine learning, behavioural science, and real-world clinical data. The company sits at the intersection of medtech, pharmaceutical, and healthcare systems, with a focus on translating AI-driven approaches into clinically validated, regulatory-compliant digital therapeutics.