Spectral AI is a pre-commercial medical device and AI company developing the DeepView System, a diagnostic tool designed to predict burn wound healing potential at the time of injury. Today, burn physicians rely on subjective assessment and weeks of observation to determine whether a wound will heal on its own or requires surgical intervention. DeepView aims to replace this approach with an immediate, objective prediction. The system combines a proprietary multispectral imaging camera — capturing tissue data across wavelengths beyond what the human eye can see — with an AI algorithm that processes wound images in roughly 20-25 seconds and delivers a binary "healing" or "non-healing" output. Target customers include clinicians at burn centers, trauma centers, and hospital emergency departments in the U.S., U.K., Australia, and Gulf Cooperation Council nations. Spectral AI has no commercial revenue today; all revenue comes from U.S. government R&D contracts, primarily from BARDA. The company submitted a De Novo application to the FDA in June 2025 and targets clearance in the first half of 2026. Upon clearance, Spectral AI plans to sell or lease the DeepView hardware to hospitals and layer on a recurring SaaS subscription covering software maintenance and algorithm updates. The BARDA contract also includes provisions to subsidize distribution of up to 170 initial DeepView systems, effectively acting as an early go-to-market channel. Since 2013, Spectral AI has received approximately $282.5M in government funding, covering substantially all R&D and clinical costs.