Spectral AI receives FDA De Novo clearance for DeepView System
27 May 2026
Spectral AI has received De Novo Classification clearance from the U.S. Food and Drug Administration for its DeepView System, allowing the company to begin commercial distribution in the United States.
The DeepView System is designed for use in burn care and can be used in burn centres, trauma centres and emergency departments. The platform uses artificial intelligence to support faster and more accurate treatment decisions in wound care.
According to Spectral AI, the technology provides a Day One diagnostic assessment of a burn wound’s healing potential. The company said the FDA clearance marks a major milestone in the commercial development of the system.
The company believes the DeepView System could help improve burn wound assessment and treatment while supporting better patient outcomes and greater cost efficiency across healthcare systems.
Source: globenewswire.com