U.S. Food and Drug Administration

U.S. Food and Drug Administration

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05/26/2026

The FDA authorized marketing of the DeepView AI System, a prescription-only adjunctive diagnostic device intended to aid healthcare provider assessment and care of burn wounds on patients.

This innovative system combines advanced imaging technology with artificial intelligence to help doctors identify areas that may not heal within 21 days, which can inform whether further treatment of the burn is needed.
This authorization is part of the FDA’s ongoing commitment to delivering innovative solutions that support improvements in patient outcomes.
https://www.accessdata.fda.gov/cdrh_docs/pdf25/DEN250028.pdf

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