Lenus Health selected by MHRA for AI Airlock
The new pilot scheme is set to revolutionize AI medical device regulation in the UK.
Lenus Health is proud to announce that its groundbreaking predictive AI for long-term condition management, Lenus Stratify®, has been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI Airlock pilot scheme. The initiative is designed to help test and improve the regulatory framework for AI-powered medical devices, ensuring they reach patients quickly, safely, and effectively.
The newly launched AI Airlock will act as a regulatory “sandbox” for Lenus Stratify, along with four other innovative AI technologies, in support of evidence development for regulatory approval under the supervision of the MHRA, in partnership with the NHS AI Lab and Team AB, the consortium of UK Approved Bodies.
Lenus Stratify: A proactive model for COPD patient care
Chronic Obstructive Pulmonary Disease (COPD) affects millions in the UK, causing breathing difficulties and frequent hospital admissions. Lenus Stratify, developed by Lenus Health, uses AI to analyse health data and predict serious outcomes from COPD, such as the risk of hospital admission. These predictions enable multi-disciplinary care teams to intervene earlier and adjust treatment plans, potentially reducing hospital admissions and improving patient quality of life.
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said
“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.
“But we need to be confident that AI-powered medical devices introduced into the NHS are safe and stay safe and perform as intended through their lifetime of use.
New AI medical devices have the potential to increase the accuracy of healthcare decisions, save time and improve efficiency
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA
“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.”
The MHRA’s AI Airlock follows a call for applications and rigorous selection process, focusing on AI-powered medical devices with the potential to deliver significant patient benefits and address regulatory challenges. The findings from the pilot, expected in 2025, will inform future AI Medical Device guidance and influence the support framework for manufacturers.
We strongly believe that predictive AI will unlock a truly preventative, risk-based approach to long-term condition management
Craig Turpie, co-founder and Chief Operating Officer at Lenus Health
Craig Turpie, co-founder and Chief Operating Officer at Lenus Health, said
“Lenus Health is excited to be part of this pioneering initiative from the MHRA, contributing to the evolution of AI medical device regulation and advancing patient care through innovative technology. We strongly believe that predictive AI will unlock a truly preventative, risk-based approach to long-term condition management, prolonging lives while reducing the overall cost of care for these patients.”
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