Spectral AI Submits De Novo Application to FDA for DeepView System

Reuters

Feb 02

Spectral AI Submits De Novo Application to FDA for DeepView System

In June 2025, Spectral AI Inc. submitted a De Novo submission to the U.S. Food and Drug Administration for its DeepView® System, a non-invasive, predictive medical device and associated software platform designed to assess the healing potential of burn wounds. The submission seeks regulatory review for the DeepView System, which combines multispectral imaging with a proprietary AI algorithm to provide clinicians with early, data-driven assessments of burn wound healing.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Spectral Ai Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9646157-en) on February 02, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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The submission seeks regulatory review for the DeepView System, which combines multispectral imaging with a proprietary AI algorithm to provide clinicians with early, data-driven assessments of burn wound healing.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Spectral Ai Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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