U.K.-based startup Fraiya has launched a multicenter clinical trial of its AI-enabled pregnancy ultrasound platform, FraiyaScan. The tool is a CE-marked Class 11a medical device certified under the EU Medical Device Regulation (MDR).
FraiyaScan supports clinicians performing a woman’s 20-week pregnancy scan by automating real-time image acquisition, quality checks, measurements, and clinical reporting. It was developed by sonographers and fetal medicine specialists, the company said.
The trial will include more than 9,500 pregnant women at four National Health Service (NHS) hospitals, and will be funded by the U.K.’s National Institute for Health and Care Research.
Fraiya originated from the iFIND project at King’s College London and Imperial College London with an €11.5 million Engineering and Physical Sciences Research Council (EPSRC) and Wellcome Trust innovation grant and the combination of two medtech venture accelerators: the London Institute for Healthcare Engineering and Cedars-Sinai Accelerator in Los Angeles, California.
“This trial will assess the effectiveness of FraiyaScan in real-world conditions,” Fraiya chief medical officer Jackie Matthew, PhD, said in a company statement. “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.”