The Medical and Healthcare products Regulatory Agency (MRHA) has selected five new technologies as part of the AI Airlock scheme, “to better understand how we can regulate artificial intelligence powered medical devices”. This includes medical devices for cancer, chronic respiratory disease and radiology diagnostic services.
The selection process followed an industry-wide call for applications earlier this year, with candidates having to demonstrate the potential of their AI-powered device. The pilot forms part of MHRA regulatory “sandbox”, said to support manufacturers to explore “how best to collect evidence that could later be used to support the approval of their product”.
The Lenus Stratify® medical device, developed by Lenus Health has joined the pilot programme, with its solution to support those affected by Chronic Obstructive Pulmonary Disease. The device uses AI to analyse health data and predict potential risks and outcomes associated with COPD.
Phillips proposed integrating AI into their existing systems, using it to summarise the “Impression” section of radiology reports. They claim this should help make the administration side of reporting “more efficient and accurate, reducing errors, omissions and miscommunication”.
A Federated AI Monitoring Service (FAMOS) has been developed by Newton’s Tree to help monitor AI performance in real time. It is said to identify and resolve issues such as AI’s ability to handle large amounts of changing data “for better reliability”.
Another medical device chosen was OncoFlow, which uses AI to create personalised management plans for cancer patients with an immediate focus on breast cancer patients and later adoption for other types of cancer.
And finally, an AI-powered medical device known as SmartGuideline has been selected to help with the risk of inaccurate and biased data being produced by LLMs. It uses a verified knowledge base which specifically trained LLM that enables clinicians to “smart-search national guidelines with normal questions”.
The AI Airlock scheme led by MHRA in partnership with NHS AI Lab and Team AB, announced their selection following the Lord Darzi report. Minister of state health, Karin Smith, commented to add, “as part of our 10 Year Health Plan, we’re shifting NHS care from analogue to digital and this project will help bring the most promising technology to patients”.
AI technology in healthcare
This month we also reported on the introduction of a new AI tool at Imperial College Healthcare. Developed by consultant cardiologist, Dr Fu Siong Ng, cardiology specialist registrar, Dr Arunashis Sau and team, the AI-ECG Risk Estimation for Diabetes Mellitus (AIRE-DM) tool is said to analyse subtle changes in EGC readings during routine heart scans, helping to detect type 2 diabetes up to 10 years in advance.
Earlier this year, £21 million in funding for AI technologies was announced by the Department of Health and Social Care. The aim to facilitate the adoption of AI technology as a way to “help diagnose patients more quickly for conditions such as cancers, strokes and heart conditions”.
AI imaging technology has reportedly helped to reduce cancer waiting times at Barking, Havering and Redbridge University Hospitals, “from three weeks to just three days”, enabling clinicians to prioritise more urgent cases.
In other news on MHRA, have been taking part in a consultation regarding proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. You can read more about that project here.
