PRISM NextGen Tech & AI: Spectral AI Achieves Key Milestone in AI-Driven Wound Care Diagnostics

Spectral AI (Nasdaq: MDAI), an AI-focused company transforming medical diagnostics for improved wound care, announced the successful completion of “truthing” for all burn center images collected across the U.S. This achievement marks a critical step in training the company’s proprietary DeepView® System to accurately predict wound healing outcomes. Building on this milestone, Spectral AI has now started truthing for images gathered from emergency departments and emergency rooms nationwide, broadening the DeepView® System’s applications.

What Is Truthing?

Truthing is a rigorous process used to develop a “ground truth” dataset by verifying whether wounds heal or require intervention. Images collected during early treatment stages are paired with biopsies, 21-day wound assessments, and expert evaluations. This data trains the AI algorithm to distinguish between wounds likely to heal and those needing medical intervention.

Major Achievements:

• Burn Centers Completion: Spectral AI’s truthing process for burn centers involved over 3,000 biopsied images, forming the largest dataset of its kind.
• Expert Collaboration: The milestone was achieved through a collaboration between burn experts, dermatopathologists, and data scientists, ensuring the technology’s precision and reliability.
• Enhanced AI Capabilities: The DeepView® System leverages advanced machine learning and clinical insights, enabling unprecedented accuracy in identifying wound healing trajectories.

Expanding to Emergency Departments

With burn center truthing complete, Spectral AI is shifting its focus to emergency care settings, collecting data from early treatment stages to adapt the DeepView® System to diverse clinical scenarios. This expansion underscores the system’s potential to revolutionize diagnostics across acute care.

Looking Ahead: FDA Submission and Product Launch

Spectral AI has completed image collection for its BARDA-supported burn study, a critical step toward FDA De Novo submission for the DeepView AI®-Burn system as a Class II medical device. Expected data results in late December 2024 will support the submission, with potential approval anticipated in the first half of 2025.

Designed to deliver fast, accurate burn-depth assessments, the DeepView AI®-Burn system aims to enhance decision-making in treating adult and pediatric burn victims, providing critical support in both burn centers and emergency settings.

“Our team remains committed to ensuring the DeepView® System delivers unmatched diagnostic accuracy,” said Dr. J. Michael DiMaio, Chairman of Spectral AI’s Board. “By incorporating diverse data, we aim to create a solution that seamlessly integrates into acute care workflows, improving outcomes across medical settings.”

Spectral AI shares rose on the announcement and are currently trading up ~30% leading the PRISM NextGen Tech and AI Index.