Spectral AI outlines U.S. regulatory pathway for DeepView system

Spectral AI provided an outline of its regulatory pathway strategy to enter the U.S. market with its flagship DeepView System for burn indication. “We have entered an exciting phase at Spectral AI with the recently announced completion of adult and pediatric patient enrollment at U.S. burn centers for our U.S. Burn Pivotal Study,” said Trudy Estridge, Sr. Director of Regulatory Affairs at Spectral AI. “The unique characteristics of DeepView AI-Burn meet criteria that, to our knowledge, no approved or cleared alternatives registered by the FDA currently possess. Therefore, the Company has decided to pursue a De Novo submission requesting classification of DeepView AI-Burn as a Class II medical device. This process provides a pathway for FDA clearance for low- or medium-risk medical devices with no existing predicate, or no substantial equivalence. We expect to submit this request in the second quarter of 2025 and, if granted, the FDA will create a new product code for the DeepView System.”