Newel Health is a digital medical device company that develops and manufactures certified Software as Medical Devices (SaMDs) for chronic disease management. The company's work spans artificial intelligence, machine learning, behavioural science, and real-world clinical data analysis, applied across cardiometabolic disease, neurology, chronic pain, and the broader pharmaceutical and medtech sectors.
The company's product portfolio includes two CE MDR Class IIa certified devices currently in clinical deployment: Amicomed, which targets hypertension management, and Rohkea, designed for chronic musculoskeletal pain. A third product, Soturi, addresses Parkinson's disease and is currently in an active clinical study. Underpinning these products is the H.Core AI platform, a proprietary system that integrates regulatory compliance, quality management systems, pre-qualified clinical modules, and machine learning capabilities for regulated medical device development.
Newel Health operates as an ISO 13485-certified legal manufacturer and holds ISO 27001 certification, with systems designed to meet HIPAA requirements. The company has multiple CE-marked products deployed in clinical settings, positioning it at the intersection of software engineering, clinical validation, and medical device regulation.
