Spectral AI Inc (NASDAQ:MDAI) has outlined its US regulatory strategy for its DeepView AI burn system, a device designed to assess burn healing potential using multi-spectral imaging and AI.
The device, which received FDA Breakthrough Device Designation in 2018, provides rapid predictions on wound healing, assisting clinicians in treatment decisions.
Spectral AI has completed patient enrollment for a pivotal study in US burn centers and plans to pursue a De Novo submission in the second quarter of 2025, requesting FDA clearance as a Class II medical device. If approved, this would establish a new product category for the system.
The company sees this as a key step in its journey to commercialize DeepView and expand its use for other medical applications.
“The unique characteristics of DeepView AI-Burn meet criteria that, to our knowledge, no approved or cleared alternatives registered by the FDA currently possess,” Trudy Estridge, Spectral AI’s senior director of regulatory affairs, explained.
“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.”
Peter Carlson, Spectral AI CEO, added that the process of developing an innovative healthcare solution is “long and challenging” and thanked his team’s dedication.
“As we pursue FDA submission for DeepView AI-Burn, we are following a process that we believe can capitalize on the platform nature of our DeepView System and expedite the commercialization of additional pipeline applications,” Carlson said. “We look forward to our future with confidence.”