Spectral AI has received UK Conformity Assessed (UKCA) authorisation for its DeepView AI-Burn predictive software.
The authorisation allows the system to aid in burn wound diagnosis within the UK.
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Spectral AI CEO Wensheng Fan said: “The completion of this milestone will allow us to sell our DeepView System in the UK and we expect to swiftly deploy six devices in the UK for customer evaluation and to begin generating revenue in the second half of this year.
“In addition, this regulatory authorisation opens up the ability to expand partnerships with regions such as the Middle East that recognise the UKCA authorisation.”
The authorisation is expected to contribute to the company’s revenue, with commercialisation in the UK anticipated in the second half of 2024. This is in addition to the $28m revenue guidance communicated by Spectral AI previously.
The DeepView System features AI algorithms to analyse patient wounds and assess clinically validated data points.
This helps differentiate between healthy and damaged tissue in a short period.
The technology is claimed to have a 92% accuracy rate.
Currently, DeepView AI-Burn is indicated for use in individuals aged 18 and above.
Spectral AI is planning to expand the technology use to the paediatric population and is initiating case studies and series with surgeons at leading burn centres.
Spectral AI UK subsidiary executive vice-president Paul Chadwick said: “The authorisation of the DeepView System could effectively obviate the need for these long observation periods, accelerating the way we manage burn wounds in the UK.”
Last year, Spectral AI secured the UKCA mark and Class 1 medical device classification from the US Food and Drug Administration (FDA) for its DeepView SnapShotWound Imaging System.
