A new generation of MRI technology developed by scientists at the University of Nottingham for disease monitoring via blood flow measurement has received Food and Drug Administration (FDA) clearance.
The new Arterial Spin Labelling (ASL) MRI software is being commercialised by the university’s spin-out company Quantified Imaging following its development by Professor Michael Chappell’s research group at the Sir Peter Mansfield Imaging Centre (SPMIC) – the birthplace of MRI at the University of Nottingham.
“This approval means the world’s leading software for analysing ASL MRI in scientific research is now available for clinical use. This is a major milestone for Quantified Imaging and we will now build upon this foundation towards our ultimate objective of enabling precision medicine in dementia treatment.”
Michael Chappell, Professor of Biomedical Imaging, School of Medicine
Understanding blood flow is crucial to diagnosing and treating multiple brain diseases such as dementia and stroke. Both the speed and amount of blood delivery reveal information about disease. For example, low blood delivery is typical of many dementias, whereas slow blood delivery can indicate vascular disease. The new software, which is compatible with the majority of existing MRI scanners, analyses scans to provide rapid whole-brain measurements of blood flow, which in turn allows doctors to monitor disease progression and how patients are responding to treatment.
ASL MRI uses the magnets within the MRI scanner to “label” blood flowing through the arteries of the neck and then track its delivery throughout the brain. By comparison, existing techniques for measuring blood flow use contrast agents or radioactive tracer compounds which means they are costly and cannot be used on vulnerable patients. The key benefit of ASL is that it doesn’t expose patients to the risks associated with contrast agents or tracers, making it safe and accessible for all patients as part of routine brain imaging.
Although not the first time ASL MRI has been available for clinical use, Quantified Imaging’s new software incorporates advanced technologies such as Bayesian inference and automatic quality control to more accurately and robustly measure blood flow than existing products currently on the market. This will give clinicians greater confidence in adopting ASL MRI as part of routine care. FDA clearance for the new software means the company can start commercial sales in the US in early 2027, opening this new development up to millions of patients in a clinical setting for the first time, with plans for a roll out to the UK at a later date.
Quantified Imaging’s next objective is to further develop this technology into a tool for optimising patient selection for new dementia treatments, starting with anti-amyloid treatments for Alzheimer’s disease. Though these treatments have the potential to slow cognitive decline, not all patients respond well to them, and they are very complex to administer. At present, QI’s software is already used in a number of clinical trials and US pilot studies. Preliminary results, which are being presented at the Alzheimer’s Association International Conference starting in London this week, indicate ASL MRI can spot which patients are responding well to treatment, thereby helping doctors manage this entirely new class of treatments.
This news also coincides with the completion of an oversubscribed seed funding round for Quantified Imaging.