MHRA confirms five technologies selected for AI Airlock Pilot

The pilot is a regulatory “sandbox” for manufacturers to work together with the MHRA, National Health Service (NHS) and Approved Bodies to better understand the risks associated with AI devices and the regulatory challenges faced by manufacturers when bringing these products to market under the current medical device framework.  

 The five technologies selected are: 

• The Lenus Stratify® developed by Lenus Health – a medical device that uses AI to analyse health data and predict serious outcomes from Chronic Obstructive Pulmonary Disorder (COPD), such as the risk of hospital admission.

• Philips’ language model for improving the efficiency and accuracy of radiology reporting.

• FAMOS (Federated AI Monitoring Service) developed by Newton’s Tree - a platform that helps hospitals, AI developers and regulators monitor AI performance in real time so that issues like drift can be resolved early.

• OncoFlow – a device that uses AI to help healthcare professionals involved in cancer care create personalised management plans for cancer patients.

• SmartGuideline - an AI-powered medical device that allows clinicians to smart-search national guidelines with normal questions.

The AI Airlock Pilot is one strand of the MHRA’s programme to reform medical device regulation in Great Britain.  The outcomes of the AI Airlock Pilot will not only assist the development of these five innovative technologies but also inform how the MHRA develops further the rules and guidance for AI powered-medical devices generally.  

By working together with industry and other stakeholders, the MHRA aims to develop a regulatory framework for AI-powered devices that is proportionate, balances quicker market access with patient safety, and removes unnecessary regulatory barriers to market entry. 

The Pilot runs until April 2025 and the findings will be published and used to inform future AI Airlock projects. 

The progress of the AI Airlock Pilot demonstrates the MHRA’s continued commitment to lead in the area of AI-powered and software based medical devices and is a key part of the MHRA’s wider strategic approach to AI.


Authored by Jane Summerfield and Alexandra Wood.