The Medicines and Healthcare products Regulatory Agency (MHRA, UK) has selected five innovative technologies for the AI Airlock programme, GOV.UK reported.
These include Lenus Stratify®, which predicts severe outcomes for COPD patients to enable earlier interventions, Philips’ AI-driven radiology reporting for greater efficiency, and FAMOS, an AI platform that monitors performance in hospitals to ensure reliability.
OncoFlow uses AI to personalise cancer care, reducing wait times and improving survival rates, while SmartGuideline helps clinicians access up-to-date national guidelines. Together, these technologies have the potential to significantly enhance diagnosis, treatment, and AI reliability in healthcare.
Selected devices must demonstrate patient benefits, innovation, and regulatory challenges. However, being chosen for AI Airlock doesn’t mean regulatory approval. Results, due in 2025, will inform future AI medical device guidance and influence UKCA marking processes.
This initiative follows Lord Darzi’s report, highlighting the need for regulatory frameworks to ensure AI devices are safe and effective in transforming the NHS. AI Airlock is part of the MHRA’s broader overhaul of medical device regulations.
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, stated: ‘New AI medical devices have the potential to increase the accuracy of healthcare decisions, save time and improve efficiency, leading to better outcomes for the NHS and patients across all healthcare settings’.
‘By examining the technologies announced today in a safe setting, in partnership with technology specialists, developers and the NHS, we can test and improve the rules for AI-powered medical devices, helping get products like these to the hospitals and patients who need them sooner,’ she added.
AI Airlock is a regulatory “sandbox” that allows manufacturers to test evidence collection under MHRA supervision in a virtual setting. This helps refine regulatory frameworks, providing a clearer market pathway and faster access to AI technologies patients.
This project is a joint effort led by the MHRA, in collaboration with the NHS AI Lab and Team AB, a consortium of UK Approved Bodies. It also brings together experts from the healthcare industry, government, academia, the Information Commissioner’s Office, and other regulatory authorities.