King's spinout Fraiya has launched The FRAIYA Study to determine whether AI can make routine pregnancy scans safer, faster and more reliable for thousands of women across the UK.
The study, led by King's College London, will assess whether AI tools developed by Fraiya Ltd can improve fetal ultrasound screening performance. Fraiya is a spinout from King's School of Biomedical Engineering & Imaging Sciences, founded by Professor Reza Razavi and Dr Jackie Matthew, as well as a talented foundation team.
Every year, thousands of pregnant women across the UK attend a routine ultrasound scan at around 20 weeks to check how their baby is developing. While this scan can detect many serious conditions, accuracy and quality can vary, and some problems, such as congenital heart defects, are still missed.
Fraiya's tools are designed to address this. By helping sonographers capture images and measurements more quickly and consistently, the tools remove the manual burden of 20-week anomaly scans, so the sonographer can focus more on the patient.
The tools also enable independent specialists to review the scans afterwards and check for any signs of concern, aiming to improve the detection of conditions that can be missed.
Funded by the National Institute for Health and Care Research, the randomised controlled trial will recruit over 9,000 participants across Guy's and St Thomas', Lewisham and Greenwich, Liverpool Women's and East Kent NHS Trusts. Alongside clinical outcomes, the study will also assess how cost-effective the AI tools are for the NHS.
"This is a defining moment for Fraiya. Launching CE-marked, AI software as a medical device, within the NHS - The FRAIYA Study represents the transition from innovation to real-world clinical implementation."
Dr Jackie Matthew, Chief Medical Officer/Co-Founder of Fraiya and Clinical Academic Sonographer, King's College London
The FRAIYA Study was launched at an event at the London Institute for Healthcare Engineering, and the team have already begun recruiting and scanning the first participants.
"Although many AI tools have been developed for medical imaging applications, very few are being evaluated prospectively. We are excited to run this large, randomised control trial of FraiyaScan and FraiyaDetect to see the clinical and health-economic impact in a real-world setting."
Professor Reza Razavi, Co-Founder and CEO of Fraiya, Professor of Paediatric Cardiovascular Science, King's College London
