MDAI news

Spectral AI has secured FDA de novo classification, now authorized to launch sales in the U.S., bolstered by $86.6M in Project BioShield funding and plans for global expansion.

Spectral AI announced FDA De Novo Classification for its DeepView System for burn wound assessment, authorizing commercial distribution in the U.S. The company also secured $31.7 million in BARDA funding and elected its board of directors at its annual stockholder meeting.

Spectral AI's DeepView System, an AI-powered medical device for burn wound assessment, received FDA De Novo classification, authorizing commercial distribution in the U.S. The clearance enables the company to commercialize its non-invasive diagnostic technology across burn centers, trauma centers, a…