# Newel Health

> Newel Health is a certified legal manufacturer of Software as a Medical Device (SaMD), developing and manufacturing AI-driven digital medical devices for chronic disease. Headquartered in Salerno, Italy. ISO 13485, ISO 9001, ISO 27001, IEC 62304, CE MDR, FDA-aligned, GDPR, HIPAA, and DiGA certified.

Newel Health builds certified SaMDs combining AI, behavioural science, and real-world clinical data across three therapeutic areas: cardiometabolic disease, Parkinson's disease, and chronic musculoskeletal pain. The company operates both as a product portfolio company and as a certified legal manufacturer for pharma and medtech partners.

## Products

- [Amicomed](https://newel.health/pipeline/amicomed): CE MDR Class IIa certified SaMD for hypertension management. Uses the Pascal algorithm to monitor blood pressure and deliver personalised lifestyle interventions. Validated across 170,000+ measurements and 2,800+ subjects. Mean systolic BP reduction of ~7.9 mmHg in uncontrolled hypertensives.
- [Rohkea™](https://newel.health/pipeline/rohkea): CE MDR Class IIa certified VR-based digital therapeutic for chronic musculoskeletal pain. Delivers cognitive behavioural therapy (CBT) through immersive virtual reality over a structured 12-week, 60-session program. Targets kinesiophobia (fear of movement). Cover study published in PAIN Journal (2022).
- [Soturi](https://newel.health/pipeline/soturi): AI-powered SaMD for personalised Parkinson's disease management. Combines wearable sensors, digital biomarkers, and a levodopa dose optimisation decision support tool. In active clinical study. Funded by the Michael J. Fox Foundation ($2.5M Phase 1 grant). Partner: Orion Pharmaceuticals.

## Platform

- [H.Core](https://newel.health/hcore): Newel Health's proprietary AI development platform for building certified SaMDs. Integrates a regulatory-compliant QMS, pre-qualified clinical module library, behavioural science engine, and AI/ML layer. Every component documented under IEC 62304. Supports CE MDR, FDA, GDPR, HIPAA, and GxP compliance by design.

## Services

- [Legal Manufacturer](https://newel.health/legal-manufacturer): Newel Health acts as certified legal manufacturer for pharma and medtech partners co-developing SaMDs. Takes full regulatory accountability from design control through post-market surveillance under EU MDR, FDA, and equivalent frameworks.

## Therapeutic Areas

- [Cardiometabolic](https://newel.health/therapeutic-areas/cardiometabolic): Hypertension and cardiovascular risk. 1.28 billion people affected worldwide.
- [Neurology](https://newel.health/therapeutic-areas/neurology): Parkinson's disease. 12 million people affected worldwide.
- [Pain](https://newel.health/therapeutic-areas/pain): Chronic low back pain. 619 million people affected worldwide.

## Science

- [Publications & Evidence](https://newel.health/science): 13 peer-reviewed publications across digital therapeutics, behavioural science, cardiometabolic disease, neurology, and chronic pain. Published in PAIN, JACC, AHA Hypertension, JMIR mHealth, Frontiers in Virtual Reality, PLOS Digital Health. 8,992+ subjects across studies. Institutional partners include IRCCS San Raffaele, University of Salerno, Geneva University Hospital, Michael J. Fox Foundation, and 15 others.

## Reference

- [Glossary](https://newel.health/glossary): Definitions of 21 key terms in SaMD regulation, digital therapeutics, and clinical AI — including SaMD, CE MDR, IEC 62304, DTx, digital biomarker, levodopa optimisation, H.Core, and more.

## Certifications

- ISO 13485 — Quality Management System for medical device manufacturers
- ISO 9001 — General Quality Management System
- ISO 27001 — Information Security Management System
- IEC 62304 — Medical device software lifecycle
- EU MDR (CE marking) — European Medical Device Regulation 2017/745
- FDA-aligned — US Food and Drug Administration alignment
- EU GDPR — General Data Protection Regulation
- HIPAA — Health Insurance Portability and Accountability Act
- DiGA — German Digital Health Applications framework

## Company

- Website: https://newel.health
- News & blog: https://blog.newel.health
- Contact: https://newel.health/contact-us
- Headquarters: Largo Abate Conforti snc, 84121 Salerno, Italy
- VAT: IT 06046410657