About Nexus Intelligence

Nexus AI CXR, engineered for the front line of lung health.

Nexus AI CXR is a CE MDR Class IIb certified chest X-ray AI solution designed to support accurate, efficient, and scalable lung health screening.

Our mission

To become the global leader in AI-powered decision support for chest X-ray screening.

Nexus Intelligence (Pty) Ltd is a medical AI technology company focused on developing clinically validated, regulatory-approved AI solutions for lung health imaging.

We specialise in scalable AI solutions supporting population screening, public health programmes, occupational health, and enterprise radiology workflows worldwide – improving detection, workflow efficiency, and patient outcomes while making high-quality AI technology more affordable and sustainable.

Published in The Lancet. Powered by Google. Trusted by clients.

From founding to certified · 3 years
2023
Google Partnership
Master Licence & Development Agreement
2024
The Lancet Publication
Top 2 of 12 CAD AI vendors · Stop TB
2025
CE MDR Class IIb Certified
December 2025 · In Clinical Use
Our journey

A disciplined, evidence-first development path.

Every milestone – from the Google partnership to CE certification – was earned through rigorous clinical validation, independent peer review, and regulatory compliance.

2023
Foundation phase
  • Master Licence & Development Agreement with Google LLC
  • Core AI integration begins
  • CE MDR Class IIb regulatory strategy defined
  • Public health pilot planning initiated
2024
Product validation
  • Independent Stop TB evaluation completed
  • The Lancet Digital Health publication
  • Nexus AI CXR product launch
  • First TB screening deployments
2025
Regulatory & scale
  • EN ISO 13485 QMS certified
  • CE MDR Class IIb approval (Dec 2025)
  • Deployments across multiple screening projects
  • Listed on Stop TB AI4HLTH platform
  • PACS & imaging vendor integrations
2026
Expansion phase
  • Enterprise & public health scale-up
  • Multi-pathology expansion (Silicosis external validation by Stop TB)
  • Multimodal AI + LLM clinical integrations
  • CE expansion and FDA in progress
  • Available through PFSCM / WAMBO
Certifications & quality

Built to regulatory standard, from day one.

Nexus AI CXR is engineered, validated, and deployed in full compliance with the international standards that matter most in medical AI.

CE
CE MDR Class IIb

EU MDR 2017/745

Class IIb certified Software as a Medical Device. Approved for deployment in institutional healthcare environments and national screening programmes.

ISO
ISO 13485:2016

Quality management

EN ISO 13485 certified Quality Management System for the design and manufacture of medical devices.

62
IEC 62304:2015

Software lifecycle

Medical device software lifecycle processes – full SOUP justification and traceability matrix maintained.

14
ISO 14971:2019

Risk management

Application of risk management to medical devices. Risk-benefit analysis maintained throughout the product lifecycle.

Partnerships

A network built for global lung health.

Nexus works in active collaboration with the world's leading institutions on AI foundation models, clinical validation, procurement, and integrated ecosystem delivery.

Google

Developed in collaboration with Google under a long-term Master Licence and Development Agreement covering the underlying machine learning models. Nexus retains full design, development, and regulatory responsibility for the commercial product.

Healthcare Framework (HCF)

Nexus AI is integrated within the Healthcare Framework clinical management platform and CloudX teleradiology service – together forming the Comprehensive Lung Health Ecosystem deployed across 20+ countries.

Stop TB Partnership

Independent external validation against 12 CAD AI vendors, external validation of the Silicosis model (Beta), and participation in TB REACH POCs in Cameroon and Vietnam.

Public & Private Deployments

Active deployments across multiple countries and Ministries of Health, the South African private mining sector for occupational lung health screening, TB REACH donation programmes, and the Nexus × Google in-kind social impact drive.

Global Fund

Quality-assessed and approved for procurement across Global Fund programmes. WHO PQ evaluation in progress – extending procurement readiness across global public health programmes.

PFSCM / WAMBO

Available for procurement through the Pooled Procurement Mechanism – extending market access across public health programmes.

Let's talk about scaling lung health screening together.

Whether you're a ministry of health, a procurement partner, or a research institution – we'd like to hear from you.