USFDAMay 26, 2026, 07:02 AM

Spectral AI DeepView System Receives FDA De Novo Classification

AI Summary

Spectral AI announced that its DeepView System received De Novo Classification from the U.S. FDA, authorizing commercial distribution in the United States. This AI-powered medical device provides a non-invasive, predictive assessment of burn wound healing potential, enabling faster and more accurate treatment decisions. The company believes this milestone will redefine burn wound care, improve patient outcomes, and enhance cost efficiency.

Key Highlights

DeepView System received FDA De Novo Classification.
FDA classification authorizes US commercial distribution.
DeepView assesses burn wound healing potential within 21 days.
Image acquisition takes 0.2 seconds; processing takes 20-25 seconds.
System trained on over 340 billion pixels of burn wound data.
Project supported by BARDA under contract 75A50123C00049.

View SEC Filing

MDAI

Medical/Dental Instruments

Spectral AI, Inc.

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