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Noticias de MDAI
Eventos de MDAI
Spectral AI Submits NTAP Application to CMS
Spectral AI announced the submission of a New Technology Add-On Payment, or NTAP, application to the Centers for Medicare & Medicaid Services, or CMS, for its DeepView System utilizing the alternative pathway. The NTAP program is designed to provide an additional hospital inpatient payment for eligible procedures involving new technologies or medical services that meet CMS requirements, helping to address the additional costs associated with incorporating innovative technologies into patient care while providing timely access to these advancements.
Spectral AI Completes First Site Initiation Visit for Clinical Study
Spectral AI announced the completion of the first Site Initiation Visit, SIV, associated with the commencement of a clinical study designed to support a label expansion of the Company's FDA-cleared DeepView System for Burn Indication to include burns involving the head, hands and feet.
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).
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