Research Dossier · Editorial Research

$150M BARDA Contract. FDA De Novo Pending. Revenue Timing Is the Noise. The Contract Is the Signal.

MDAI · NASDAQ · Healthcare · Published January 2026

$150M BARDA contract. DeepView FDA De Novo application submitted; determination pending. Revenue of $19.7M in FY2025 down from $29.6M in FY2024 due to contract milestone timing, not commercial failure. $15.4M cash at year-end.

What This Company Is

Spectral AI built an AI system that looks at a burn wound and tells doctors how deep it is; something that currently requires waiting days for the wound to declare itself. The U.S. government's medical research agency (BARDA) gave them a $150M contract because the technology works. FDA approval is pending. The revenue comes from the government contract while they wait for FDA clearance. Cash grew from $3.7M to $15.4M in a year because the government keeps paying milestones.

Analyst Note

"$150M BARDA contract. DeepView FDA De Novo application submitted and pending. Cash grew from $3.7M to $15.4M in twelve months; the government contract is funding the operation while the FDA decides."

The Bottom Line

Watch for FDA De Novo determination announcement. This is the filing that changes the commercial timeline. Watch FY2026 BARDA revenue milestones for whether the $18.5M guidance is maintained. Any military deployment announcement beyond the existing contract validates the technology.

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