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Noticias de MDAI
Eventos de MDAI
Spectral AI Appoints Darcy Bajko as Chief Commercial Officer
Spectral AI announced the appointment of Darcy Bajko as chief commercial officer, effective July 31. Bajko will lead the commercial functions in support of Spectral AI's global launch of its DeepView System for burn indication, which was granted De Novo Classification by the U.S. Food and Drug Administration in May. "Darcy's appointment further strengthens our executive team and represents an important step for Spectral AI as we pivot from product development to disciplined commercial execution," said Vincent Capone, CEO.
Spectral AI's DeepView System Receives FDA De Novo Classification
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 Appoints David McGuire as CFO
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).
FY26 Revenue Outlook Reflects Development of DeepView System
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.
Spectral AI Q4 Revenue $3.8M Beats Expectations
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."
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