HAI Solutions Receives FDA De Novo Grant for QIKCAP System: Pioneering UVC Technology for Microbial Reduction on Needleless IV Connectors

HAI Solutions, a leading innovator in ultraviolet (UVC) microbial reduction medical devices, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its ...
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U.S. FDA Grants IceCure Medical's Appeal: Reopens De Novo Classification Request for Marketing Authorization of ProSense® for Early-Stage Breast Cancer

IceCure to submit full 5-year dataset from entire ICE3 study population to the FDA this spring, ahead of previous expectation CAESAREA, Israel, Jan. 30, 2024 /PRNewswire/ -- IceCure Medical Ltd. (ICCM ...
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SS Innovations International, Inc. Plans FDA Submission for SSi Mantra 3 Surgical Robotic System in July 2025

SS Innovations plans to submit a De Novo request to the FDA for its SSi Mantra 3 surgical robotic system in July 2025. SS Innovations International, Inc. announced plans to submit a De Novo ...
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MDAI: DeepView De Novo Submission

Last week, Spectral AI, Inc. (NASDAQ:MDAI) announced the submission of its De Novo 510(k) marketing clearance application to the FDA for the DeepView system in burn diagnosis. The submission includes ...
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SS Innovations to Submit De Novo Application to the FDA for the SSi Mantra 3 Surgical Robotic System for Multiple Indications

FORT LAUDERDALE, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (SSII) (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic ...