Fraiya has achieved several milestones, including National Health System (NHS) clinical evaluation, regulatory approval and pre-seed round, signaling its emergence as a serious player in maternal health innovation.

The company’s core product, FraiyaScan, supports clinicians during the 20-week anomaly scan by automating real-time image acquisition, quality checks, measurements, and clinical reporting assistance. Built from within the NHS and co-designed with sonographers and fetal medicine specialists, the tool integrates seamlessly into existing scanning workflows and ultrasound infrastructure, offering real-time support without disruption.

A Trial for AI in Obstetric Imaging

Working with King’s College London, Fraiya is launching a prospective multi-center randomized controlled trial of FraiyaScan, alongside an artificial intelligence (AI)-assisted second review service, for more than 9,500 pregnant women across four NHS hospitals. The study is one of the first to examine the clinical and health economic evaluation of an AI imaging tool.

“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,” Fraiya Chief Medical Officer and clinical academic sonographer Dr. Jackie Matthew said. “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.”

Funded by the U.K.’s National Institute for Health and Care Research, the trial goes beyond performance metrics, measuring cost-effectiveness, workflow efficiency, and impact on workforce and patient experience. It addresses a critical gap in the literature; while AI is rapidly entering imaging, evidence for its impact on real-world healthcare remains virtually absent.

CE Marking Under EU MDR

FraiyaScan is now a CE-marked Class IIa medical device, certified under the EU Medical Device Regulation (MDR) by Scarlet NB. The company’s regulatory submission was led internally by Fraiya Chief Technology Officer Dr. Samuel Budd, with support from Jacqueline Beddoe-Rosendo and the medical engineering quality and regulatory team at King’s, ensuring clinical safety and scalability. This milestone enables commercial use in hospitals and clinics across the United Kingdom and European Union, and demonstrates Fraiya’s commitment to clinical rigor and market readiness.

Having closed a pre-seed funding round, Fraiya collected £3.5 million from grants, awards, venture capital, and angel investment since October 2024. Backed by RAW Ventures, Cedars-Sinai Ventures, and a syndicate of Healthtech and AI-focused angel investors, the money will be used to finance:

• Clinical deployment across the United Kingdom and European Union
• Additional regulatory submissions and approvals, including to the U.S. Food and Drug Administration
• Expansion into adjacent product lines
• Clinical and academic R&D support

Fraiya originated from the iFIND project at King’s College London and Imperial College, a £10 million EPSRC and Welcome Trust innovation grant at one of Europe’s Imaging Research Centers. The founding team combines deep technical and clinical expertise in AI, imaging science, digital and maternofetal health.

Fraiya is the alumnus of two medtech venture accelerators that are working to build AI to fit clinical workflow—the London Institute for Healthcare Engineering, and Cedars-Sinai Accelerator in Los Angeles.

“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,” chief trial investigator and Fraiya CEO Reza Razavi stated. “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.”

“Excited to be building at the intersection of AI, clinical practice, and product development at Fraiya,” Dr. Budd added. “With CE marking achieved, a trial on the horizon, and our pre-seed round complete, we’re moving fast toward real-world impact in prenatal care.”

Fraiya is a startup from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, founded and led by a team of expert clinicians and engineers. Its goal is to create AI-powered tools for pregnancy ultrasound that change the way clinicians scan—improving medical diagnoses, empowering healthcare professionals, and enhancing care for patients.