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The MHRA has set out its strategic approach to AI in response to a white paper published in 2023 by Government. This pilot project is a key part of that approach. It will help the Agency to identify and address the challenges for regulating standalone AI medical devices (AIaMD), initially seeking out and supporting 4-6 virtual or real-world projects through simulation. This will allow us to test a range of regulatory issues for these devices when they are used for direct clinical purposes within the NHS.
The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across sectors. The AI Airlock is a world-leading version in healthcare, designed to assist in safe development and deployment of AIaMDs, and this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.
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NHS patients in England will benefit from faster access to the most innovative and cutting-edge medical technologies under new plans.
Proposals set out in a joint NHS England and NICE consultation outline a new route for MedTech developers to access NHS funding to fast-track clinically and cost-effective products for use by the healthcare system. The plans will ensure the growing number of game-changing products recommended by NICE can be introduced to the NHS on a large-scale to improve patient outcomes.
The proposals in the consultation document have been developed by NHS England and NICE with input from the Department of Health and Social Care and other partners, including the Office for Life Science (OLS) and the Medicines and Healthcare products Regulatory Agency (MHRA).
Read more: NHS and NICE plan to adopt innovative MedTech quicker
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Tens of thousands of children and adults living with type 1 diabetes across England are set to receive an ‘artificial pancreas’ in a world-first initiative being rolled out by the NHS.
The groundbreaking device continually monitors a person’s blood glucose, then automatically adjusts the amount of insulin given to them through a pump. Local NHS systems will start identifying eligible people living with type 1 diabetes who health chiefs believe could benefit from the Hybrid Closed Loop system- sometimes called an artificial pancreas – from today. There are currently 269,095 people living in England with type 1 diabetes.
The technology will mean some people with type 1 diabetes will no longer need to inject themselves with insulin but rely on technology to receive this life saving medication. This can also help prevent life-threatening hypoglycaemic and hyperglycaemia attacks, which can lead to seizures, coma or even death for people living with type 1 diabetes.
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Hundreds of NHS patients with advanced Parkinson’s disease are set to benefit from a portable drug infusion that is gradually released around-the-clock to help better control their symptoms. The treatment, called foslevodopa–foscarbidopa, will now offer an additional option for certain patients experiencing movement-related symptoms and whose condition is no longer responding to their oral medicines.
The easy-to-use infusion is delivered through a cannula under the skin and controlled by a small automatic pump worn 24 hours a day to help steadily manage patients’ symptoms with fewer side effects. It works by releasing a combination of medications into the body, with the drug foslevodopa being turned into the chemical dopamine, which can better transmit messages between the parts of the brain and nerves that control movement.
Read more: NHS rolls out ‘wearable’ 24-hour infusion for advanced Parkinson’s
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Urinal mats in public places in England will begin to carry blood in pee cancer warnings for men, as part of a major new NHS earlier diagnosis drive.
The NHS and P-Wave, a leading urinal products brand, are working together to put the message “Blood in your pee? Contact your GP practice” on urinal mats in thousands of men’s toilets across the country. Pubs, restaurants, shops, hotels and sports stadiums will be among the public places using the lifesaving mats with men’s workplaces also targeted.
Passing blood in pee – even just once – is a common symptom for bladder, kidney or prostate cancers, which are all among the ten most prevalent cancers in the country, and generally affect men more than women.
An ultrasound of the urinary tract can help assess the size of a bladder tumour and whether a bladder cancer has spread. Ultrasound is able to differentiate between fluid-filled cysts and solid tumours, however, it cannot determine if a tumour is cancerous.
