MDAI News & Events

Spectral AI announced that the U.S. Food and Drug Administration, FDA, granted De Novo Classification for its DeepView System. With this classification, Spectral AI is authorized to commence commercial distribution activities in the United States. The DeepView System is intended for use in burn care in various settings, including burn centers, trauma centers, and emergency departments.

Spectral AI (MDAI) announced the appointment of David McGuire as the company's CFO, effective May 4. Prior to joining Spectral AI, he served as the chief accounting officer of Solo Brands (SBDS).

Reports Q4 revenue $3.8M, consensus $2.92M. Q4 EPS included a $4.0M gain in the fair value of the Company's warrant liability. "2025 was a pivotal year for Spectral AI, highlighted by the submission of our De Novo 510 application to the FDA of our DeepView System for burn indication," said Vincent Capone, CEO of Spectral AI. "We continue to make significant progress along numerous fronts in preparation for the anticipated commercialization of this innovative diagnostic device. The reception of our technology at burn conferences in the U.S., UK, and Europe has been exceptional."

FY26 revenue view reflects the continued development of the Company's DeepView System through the BARDA PBS Contract. This guidance does not include any material contributions from the sale of the DeepView System for the burn indication.