AI-enabled pregnancy ultrasound to be trialled in NHS hospitals

An AI obstetric imaging tool will be trialled across four NHS hospitals to help identify congenital problems at the 20 week pregnancy scan. UK-based FemTech startup Fraiya is working with King’s College London to compare traditional ultrasound scans with AI-supported screening using the Fraiyascan solution, which supports clinicians during the 20-week anomaly scan by automating real-time image acquisition, quality checks, measurements, and clinical reporting assistance. Congenital abnormalities affect roughly 2% of pregnancies in the UK, meaning that timely and accurate detection is critical for better neonatal outcomes and informed parental decision-making The clinical trial is due for a phased launch from winter 2025 and will run for 12 months, involving more than 9,500 pregnant women at Guy’s and St Thomas’ NHS Foundation Trust, Lewisham and Greenwich NHS Trust, Liverpool Women’s University Hospital and Royal Devon University Healthcare NHS Foundation Trust. Professor Reza Razavi, chief executive at Fraiya and chief investigator of the trial, said: “We see this trial as a turning point. It’s not just about proving our AI tools work, it’s about proving they add value to the health system. “As a clinician who looks after babies with congenital problems, I see the difference between those who are diagnosed in pregnancy and get planned care with parents who are fully informed and prepared for what’s to come, and those who unfortunately were not picked up during the pregnancy scans, who arrive at our hospital very unwell and without a diagnosis, with very anxious parents, and have a more difficult journey. “Fraiya’s mission is to address this problem of a lack of diagnosis during pregnancy, so all parents are aware of congenital problems with their babies, and babies are given the best care right from birth.” The trial, funded by the National Institute for Health and Care Research, will measure cost-effectiveness, workflow efficiency, and impact on workforce and patient experience. Fraiya originated from the iFIND project at King’s College London and Imperial College, a £10 million Engineering and Physical Sciences Research Council and Welcome Trust innovation grant. Its product Fraiyascan is a CE-marked Class 11a medical device, which integrates into existing scanning workflows and ultrasound infrastructure. Dr Jackie Matthew, chief medical officer and clinical academic sonographer at Fraiya, said: “We’re focused on leveraging the unique capabilities of ultrasound and developing solutions to make it smarter, faster, and more reliable, with clinicians at the centre of that transformation. “This trial will assess the effectiveness of FraiyaScan in real world conditions. “Importantly, the frontline staff and patient feedback will help us to understand the acceptability of the technology, where time-pressured scans, staffing gaps, and service variability, that can affect outcomes, may also impact the performance and adoption of AI-based innovations.” If the trial proves successful, AI screening tool could be integrated into NHS workflows, leading to a nationwide shift in fetal anomaly detection. The results, expected in early 2027, could also influence global standards for prenatal care. Fraiya recently closed its pre-seed round, with £3.5m in funding from grants, awards, VC and angel investment since October 2024.