DALLAS, June 30, 2025 - Spectral AI $(MDAI)$, a leader in AI-driven medical diagnostics, announced the submission of its De Novo 510k marketing clearance application to the U.S. Food and Drug Administration (FDA) for its innovative DeepView® System. This submission marks a significant milestone for Spectral AI as it seeks to bring its novel burn care diagnostic device to the U.S. market. The DeepView System, which received Breakthrough Device Designation from the FDA in 2018, leverages multi-spectral imaging and AI algorithms to assess burn healing potential, providing clinicians with immediate, data-driven insights to enhance patient care. The development and regulatory efforts for this technology have been supported by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA under multiple contracts with Spectral MD, Inc., a wholly-owned subsidiary of Spectral AI.
免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。