Spectral MD Holdings Ltd (AIM:SMD) said it has completed enrolment for the Deepview Burn AI training study being funded by the US government research agency BARDA.
DeepView AI-Burn is non-invasive imaging that lets physicians assess the severity of burns in mass-casualty events instantaneously.
In August, an initial training study in eleven burn centres was expanded to include paediatric and emergency cases.
A new, separate, validation study using Deepview is scheduled to get underway in the second half of 2023 and will generate an independent dataset from subjects enrolled across different US sites.
This is a requirement of US regulator, the Food & Drug Administration (FDA), said Spectral MD, ahead of regulatory submission for DeepView AI-Burn, which is planned in 2024.
In a statement, Wensheng Fan, Spectral MD’s chief executive, commented: "The completion of enrollment in our Burn AI Training Study represents a significant milestone for Spectral MD, as it meets our contractual obligations with BARDA, paving the way for the final stage of clinical development for DeepView AI-Burn.
“With BARDA's invaluable support, we anticipate initiating our Burn AI Validation Study in the second half of 2023.”