A UK clinical study will evaluate Spectral AI’s DeepView System in anatomically complex burn areas, with a burns and plastic surgeon leading the first study site.
Spectral AI an artificial intelligence company focused on medical diagnostics for wound care, has completed the first site initiation visit for a clinical study designed to support a label expansion of its US Food and Drug Administration-cleared DeepView System to include burns involving the head, hands, and feet.
The site initiation visit was conducted at Pinderfields Hospital in Wakefield, UK, under the leadership of principal investigator Preetha Muthayya, consultant burns and plastic surgeon and clinical lead for burns. Pinderfields Hospital, part of the Mid Yorkshire Teaching NHS Trust, provides care for adult and pediatric patients with serious and life-threatening burn injuries.
The completion of site-readiness requirements marks the operational launch of the study and allows Pinderfields Hospital to begin patient enrollment.
Addressing Anatomically Complex Burn Areas
The study aims to generate additional clinical evidence supporting the use of the DeepView System in burn areas where timely and accurate assessment of a wound’s healing potential can be particularly important to treatment planning.
“Completion of the first site initiation visit is an important step in advancing our strategy to broaden the potential clinical utility of the DeepView System,” says Vincent Capone, CEO of Spectral AI, in a release. “Burns involving the head, hands and feet present unique clinical considerations, and we believe the ability to provide clinicians with rapid, objective information regarding healing potential in these anatomically complex areas could be especially valuable. This study builds on the clinical and regulatory foundation established by our FDA-cleared DeepView System for Burn Indication and reflects our commitment to expanding the technology’s applicability for burn-care providers and their patients.”
Muthayya says, “We are delighted to be the first site to complete our site initiation and very much look forward to enrolling patients into this label expansion study,” in a release.
Study Design and Timeline
The prospective training and validation study, titled “Clinical Study of the DeepView AI-System for Assessment of Thermal Burn Healing Potential in Hands, Feet and Head/Face Training and Validation Label Expansion Study,” is expected to enroll adult and pediatric patients with qualifying thermal burns involving the hands, feet, or head and face.
Participants will be imaged with the DeepView System within 72 hours of injury, with healing outcomes assessed through 21 days. The resulting image dataset will support both algorithm training and independent validation of system performance. The DeepView System will be used in a blinded, observational capacity and not to direct patient care.
The study will be conducted at multiple sites in the UK and is expected to be completed in 2027.
About the DeepView System
The DeepView System is a non-invasive, predictive medical device that combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of areas within burn wounds. It was granted De Novo Classification by the FDA in May 2026 and received its initial UKCA authorization in the United Kingdom in February 2024.
The system provides physicians with an immediate, data-driven assessment of whether areas within burn wounds are unlikely to heal within 21 days and may require significant medical intervention. Image acquisition takes 0.2 seconds, with image processing and AI model classification completed in approximately 20 to 25 seconds. The DeepView System is trained and tested against a proprietary and clinically validated database of over 340 billion pixels of burn wound image data.
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