Fraiya, a prenatal ultrasound startup spun out of King's College London, announced on September 9, 2025, that it closed a £3.5 million pre-seed round led by RAW Ventures and Cedars-Sinai Health Ventures. The funding will support clinical deployments across the UK and EU, regulatory filings with the FDA, and expansion of the company's AI-powered imaging platform.
The technology addresses a persistent challenge in obstetric care: inconsistent quality in mid-trimester anomaly scans, the detailed 20-week ultrasound that screens for fetal abnormalities. Scan accuracy varies widely depending on operator skill and equipment, creating gaps in diagnostic reliability. Fraiya's software automates image capture and measurements, then applies a secondary AI review layer designed to catch overlooked findings and reduce variability between clinics.
The company's flagship product, FraiyaScan, has secured a CE mark in Europe and offers real-time, zero-click image capture with automated biometry. According to the startup, the tool shortens scan times and eases cognitive load for sonographers. An FDA submission is currently under review. A second product, FraiyaDetect, remains in development and will focus on AI-assisted structured review for diagnostic confidence; CE marking is pending.
Prof. Reza Razavi, CEO and co-founder, previously served as vice president of research at King's and led fetal-cardiac work at Guy's & St Thomas' NHS Foundation Trust. Dr. Jackie Matthew, chief medical officer and co-founder, is a clinical academic sonographer. Dr. Sam Budd, chief technical officer, earned a PhD in medical image computing from Imperial College London. The company lists approximately 17 employees on LinkedIn, within a reported range of 11–50 employees.
Fraiya is midway through The FRAIYA Study, a prospective randomized trial spanning four NHS trusts and targeting enrollment of approximately 9,500 patients. Funded by the National Institute for Health and Care Research, the trial runs through mid-2027 and measures scan duration, anomaly detection rates, and cost-effectiveness. "We are excited to run this large, randomized control trial... to see the clinical and health-economic impact in a real-world setting," Razavi said in a university announcement earlier this year.
The startup's technology draws on more than a decade of research from King's, Imperial, and Guy's & St Thomas'. Fraiya cited the PROMETHEUS trial, published in NEJM AI in 2025, in which several co-founders disclosed shareholding interests.
In June, Fraiya announced a partnership with Canon Medical Systems Europe to integrate its AI workflow into Canon's ultrasound platforms, initially targeting European markets. "This collaboration represents an exciting step forward in bringing practical, workflow-focused AI innovation into prenatal ultrasound," said Satoshi Matsunaga, European director of ultrasound at Canon Medical Systems Europe. Fraiya also exhibited at the ISUOG World Congress, a major gathering for ultrasound in obstetrics and gynecology.
The competitive landscape is tightening. Sonio, a French rival, secured CE marking in 2024 and has cleared multiple FDA 510(k) submissions, including a special clearance for its Sonio Detect v3 product earlier this year. BioticsAI, based in the US, obtained FDA 510(k) clearance for prenatal ultrasound quality and anatomical completeness tools in January, according to TechCrunch.
Fraiya formally incorporated on November 13, 2023, and participated in the Cedars-Sinai Accelerator, which appears among the portfolios listed by Cedars-Sinai Health Ventures. "This is a defining moment for Fraiya," Matthew said. "The FRAIYA Study represents the transition from innovation to real-world clinical implementation."
The broader push toward AI-assisted prenatal imaging reflects both promise and caution. While automation may help standardize scans across less-experienced operators, regulatory scrutiny remains high and clinical validation studies are still unfolding. For Fraiya, the NHS trial will likely prove decisive in establishing whether the efficiency gains translate into measurably better outcomes for mothers and infants.
