Dermatology
DeepView AI System
Spectral MD, Inc.
UKCAFDA
FDA-cleared AI medical device
Wound-imaging system whose AI-Burn software analyses images of thermal burn wounds to detect deep burn tissue (deep partial-thickness and full-thickness) and highlights areas unlikely to heal within 21 days with conservative treatment alone. It also calculates wound area and percent total body surface area burned. It aids physicians alongside clinical assessment, is not a stand-alone diagnostic, and its contour does not set precise excision margins.
FDA Submission Metadata
- Submission number
- DEN250028
- Decision date
- May 2026
- FDA panel
- General and Plastic Surgery
- Product code
- SHY
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals