Spectral AI has completed paediatric patient enrolment in a pivotal study evaluating the company’s AI wound diagnostics platform DeepView.

The DeepView system uses algorithms to analyse multispectral imaging of wounds against a burn biopsy tissue database. Spectral AI says its device can help predict wound healing outcomes and support clinical decision-making.

One of the most critical decisions when treating burn victims is assessing how deep the burn is and whether surgery is required. Distinguishing between healthy and damaged tissues can help avoid unnecessary surgeries.

Currently, the technology is being evaluated in a pivotal study to validate the AI algorithms as the company looks ahead to US Food and Drug Administration (FDA) approval.

Spectral AI said it aims to complete the study in Q4 this year, with approval prospects slated for 2025.

The non-invasive system has already received the regulatory green light for adults in the UK in February 2024.

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Spectral AI states that DeepView can be used immediately upon a child’s arrival at a hospital or burn centre.

The company secured a contract with the Defense Health Agency (DHA) and the US Army Medical Material Development Activity (USAMMDA) to support the development of a handheld version of its system for use by military personnel in the field.

While AI transforms burn assessment, the burn treatment space is also seeing advancements. Iceland-based Kerecis has made a name for itself with its fish skin-derived tissue-transplant products. The company has a patented technology platform that uses wild Atlantic cod skin to treat burns and other acute and chronic wounds. The potential of Kerecis’ devices caught the eye of Danish giant Coloplast, who paid $1.3bn to acquire the company in July 2023.

The wound care management market is expected to total $38.8bn by 2030, with a CAGR of 3.4%, according to analysis by GlobalData.

The study’s lead investigator Dr Jeffrey E Carter said: “We have met paediatric enrolment goals for burn centres at an unprecedented six months. We are continuing to enrol adult patients and paediatric patients through emergency departments to enrich and validate the DeepView algorithm.”