Spectral AI DeepView System Performs, Plans Product Launch In 2026

Spectral AI Inc. MDAI revealed Monday the performance results of its DeepView System in connection with the completion of its Burn Validation Study.

Spectral AI, which focuses on medical diagnostics for wound care, is developing the DeepView System. The goal is to develop a predictive device to offer clinicians an immediate and objective assessment of a burn wound's healing potential before treatment or other medical intervention.

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The DeepView System’s image processing algorithm utilizes multispectral imaging. It’s trained and tested against a proprietary database of more than 340 billion clinically validated data points.

The DeepView System is non-invasive and cart-based, allowing for mobility within the healthcare setting.

The Burn Validation Study, began in January 2024 and concluded in March 2025. It represented one of the largest burn trials ever conducted in the U.S.

Spectral AI obtained data from 164 total patients, including 115 adult and 49 pediatric patients.

Key findings included the following:

Sensitivity: The DeepView System demonstrated a statistically significant improvement in identifying non-healing tissue compared to burn physicians, as judged on sensitivity.
- At the image-wise level, the DeepView System scored 86.6%, while clinical judgment annotation (CJA) of burn physicians scored 40.8%.
- At the pixel-wise level, the DeepView System scored 81.9%, and the CJA of burn physicians scored 38.8%.
Dice Score: The DeepView System achieved statistically significant higher Dice Scores when compared to those derived from burn physicians' CJA, representing the improved pixel-wise evaluation between predicated and true segmented wound areas with the DeepView System performing at 68.5% and burn physician's CJA at 39.2%.
Specificity: The Deepview System significantly outperformed the anticipated results for image-wise specificity in segmenting non-healing wound areas, with a result of 61.2% (versus an anticipated result of 36.0%) and a CJA of 79.1%, reflecting burn physicians’ conservative assessment of burn areas.

Spectral AI plans to submit these results to the FDA as part of its regulatory submission by the end of the second quarter of 2025 and hopes to have the FDA grant the DeepView System’s De Novo Classification Request in early 2026.

Price Action: MDAI stock closed at $1.68 on Tuesday.

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