UK femtech startup Fraiya has launched a multi-center NHS trial of its AI-powered pregnancy ultrasound technology, following CE marking approval and completion of a £3.5 million pre-seed funding round backed by RAW Ventures, Cedars-Sinai Ventures, and healthcare-focused angel investors. The company will test its FraiyaScan system across four NHS hospitals with over 9,500 pregnant women.
FraiyaScan supports clinicians during 20-week anomaly scans by automating real-time image acquisition, quality checks, measurements, and clinical reporting. The system integrates with existing ultrasound infrastructure without disrupting established scanning workflows.
The prospective randomized controlled trial, conducted with King’s College London and funded by the UK’s National Institute for Health and Care Research, represents one of the first large-scale studies evaluating clinical and health economic impacts of AI imaging tools in obstetrics. The study will measure cost-effectiveness, workflow efficiency, and effects on workforce and patient experience beyond standard performance metrics.
“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,” said Professor Reza Razavi, Fraiya’s CEO and chief investigator of the trial. “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.”
Fraiya received CE marking as a Class IIa medical device under EU Medical Device Regulation, enabling commercial use across the UK and European Union. The regulatory submission was led internally by CTO Dr Sam Budd with support from King’s College London medical engineering teams.
The capital will support clinical deployment across the UK and EU, additional regulatory submissions including FDA approval, and expansion into adjacent product lines.
“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,” said Dr Jackie Matthew, Fraiya’s Chief Medical Officer and clinical academic sonographer.
The company originated from the iFIND project at King’s College London and Imperial College, a £10 million research grant from EPSRC and Wellcome Trust. The trial addresses a significant gap in AI imaging evidence, as real-world healthcare impact data remains limited despite rapid AI adoption in medical imaging.
Fraiya launched in October 2024 from partnerships with King’s College London, Imperial College, Guy’s and St Thomas’ NHS Foundation Trust, and King’s College Hospital NHS Foundation Trust.
