Precise about what it is, and honest about where it stands.
Verityn is a medical device and clinical decision support tool under the applicable frameworks in the markets where it operates. This page sets out the regulatory posture by region, the intended use, and the clinical safety framework. Nothing here should be read as a claim of regulatory clearance where that authorisation has not yet been granted.
Verityn is intended to assist a qualified radiologist or clinician by providing a computer-generated second read of medical images. The system presents candidate findings with a confidence value, a localisation region, and a plain-language reason for each flag.
Verityn is not intended for autonomous reporting, unsupervised use, or use as a primary diagnostic tool. The qualified clinician reviews every flag, weighs it against the full clinical picture, and makes the final clinical decision. Verityn does not diagnose. The clinician always decides.
Regulatory posture across the markets we serve.
Verityn's regulatory status differs by jurisdiction. We are committed to honest, region-specific communication. The status shown here reflects the position as of the date of this page and will be updated as each pathway progresses.
UKCA
United Kingdom
Verityn is developed under a programme aligned with the UK Medical Devices Regulations 2002 (as amended post-Brexit) and MHRA guidance on AI as a medical device. UKCA technical file preparation is in progress. Verityn is not yet UKCA-marked. UK deployments are configured to support NHS data security requirements, including data residency within the UK.
- UK MDR 2002 (as amended) alignment
- MHRA AI as a Medical Device guidance context
- DTAC-compatible deployment model
- UK data residency available
CE / MDR
European Union
CE marking under EU MDR 2017/745 is in progress. Verityn is developed in line with MDCG guidance on software as a medical device and AI. The clinical evaluation follows MEDDEV 2.7/1 Rev 4 methodology. Until CE marking is complete, Verityn is not authorised for clinical use in EU member states.
- EU MDR 2017/745 technical file in progress
- MDCG SaMD guidance alignment
- ISO 13485 quality management system
- EEA data residency available
FDA
United States
Verityn has not received clearance or approval from the US Food and Drug Administration. It is not available for clinical use in the United States at this time. The FDA regulates AI-based clinical decision support of this type as a medical device. Any future US pathway would follow the appropriate SaMD classification and review process.
- No FDA clearance or approval at this time
- Not available for US clinical use
- Future pathway: SaMD classification assessment
- Not available: De Novo, 510(k), or PMA
Varies
Rest of world
Regulatory requirements for AI-based clinical decision support tools vary significantly by jurisdiction. For any market not listed above, Verityn assesses local requirements before deployment. On-premise deployment is available for institutions that need Verityn to run within their own infrastructure while local regulatory pathways are evaluated.
- Assessed case by case with local regulatory counsel
- On-premise deployment available
- No identifiable data need leave the institution
- Contact our regulatory team to discuss
Regulatory status is as of 2026. This page is updated as pathway status changes. Contact our regulatory team for the current position in your jurisdiction.
Clinical risk management from design through to deployment.
Verityn operates a clinical risk management framework aligned with NHS Digital's DCB0129 (clinical risk management for health IT systems) and DCB0160 (clinical risk management for deployment). A named Clinical Safety Officer holds accountability for the safety case.
Clinical Safety Officer
The Clinical Safety Officer (CSO) role is held by Dr. Sofia Marchetti, Head of Clinical Affairs. The CSO is a qualified healthcare professional with formal responsibility for the clinical safety case, the hazard log, and the clinical safety report for each software version.
Hazard log and risk assessment
A hazard log identifies and assesses clinical hazards arising from the use, misuse, or failure of Verityn. Hazards are rated by severity and likelihood, and control measures are documented. The log is reviewed at each software release and at defined intervals during post-market surveillance.
Clinical safety case
A clinical safety case document summarises the safety evidence and the argument that Verityn is safe for use in its intended clinical context. The safety case is updated with each major release and is available on request to deploying institutions.
Deploying organisation obligations
Institutions deploying Verityn have their own DCB0160 obligations. Verityn provides a hazard log, safety case, and clinical risk management documentation to support the institution's own clinical risk assessment. Our clinical team is available to assist.
The questions governance and procurement teams ask first.
Honest answers on regulatory status, intended use, and what in-progress means in practice.
Questions for our regulatory or clinical team?
Our regulatory team can discuss jurisdiction-specific deployment, documentation, and clinical safety obligations. Our evidence page sets out the validation methodology.
Speak to our regulatory and clinical team.
Deployment in any jurisdiction depends on local regulatory requirements. Our team can discuss your context, provide documentation, and support your institution's own clinical risk management process.