Spectral AI, Inc. $MDAI

What the company doesAI summary of filing

Spectral AI develops the DeepView System, an artificial intelligence-powered medical imaging platform designed to predict burn wound healing outcomes. The DeepView System combines multispectral imaging technology with proprietary AI algorithms to provide clinicians with an objective assessment on the first day of treatment, distinguishing between tissue that will heal and tissue that will not heal. The company received UKCA marking in the UK in March 2024 and submitted a De Novo application to the FDA in June 2025, with expected FDA clearance anticipated in the first half of 2026. The company is currently pre-revenue from commercial sales, funding its operations primarily through government contracts with BARDA (Biomedical Advanced Research and Development Authority) and the Defense Health Agency, which have provided approximately $282.5 million since 2013, including a current contract valued at up to $150 million. [10-K 2026-03-25]

Segments: DeepView System (burn indication), DeepView SnapShot M (handheld device), 3-D Wound Measurement Technology, Pipeline applications (diabetic foot ulcer, amputation site analysis, soft tissue indications)