Spectral AI Announces First Site Initiation Visit for DeepView System™ Clinical Study Supporting Label Expansion Strategy to Burns of the Head, Hands, and Feet
Key Highlights
- ➤First SIV launches MDAI’s label-expansion clinical study at Pinderfields Hospital
- ➤Study targets DeepView System™ use in burns involving head, hands and feet
- ➤Pinderfields Hospital can begin enrolling adult and pediatric burn patients
- ➤Multi-site UK study expected to complete in 2027
Expert Statements
Vincent Capone, Chief Executive Officer of Spectral AI
“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”
Vincent Capone, Chief Executive Officer of Spectral AI
“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.”
Vincent Capone, Chief Executive Officer of Spectral AI
“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.”
Vincent Capone, Chief Executive Officer of Spectral AI
“We are grateful for the commitment of our clinical collaborators and the patients who participate in this important research, and look forward to advancing the study in support of a potential label expansion.”
Preetha Muthayya, Consultant Burns and Plastic Surgeon and Clinical Lead for Burns at Pinderfields Hospital
“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.”
DALLAS, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the completion of the first Site Initiation Visit (“SIV”) associated with the commencement of a clinical study designed to support a label expansion of the Company’s FDA-cleared DeepView System™ for Burn Indication to include burns involving the head, hands and feet.
The SIV was conducted at Pinderfields Hospital, Wakefield, UK under the leadership of Principal Investigator Dr. Preetha Muthayya, Consultant Burns and Plastic Surgeon and Clinical Lead for Burns. Pinderfields Hospital is part of the Mid Yorkshire Teaching NHS Trust and provides expert care for adult and pediatric patients with serious and life-threatening burn injuries.
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