Stereotaxis Achieves CE Mark In Europe And Submits 510(k) To FDA For GenesisX Robotic System
Portfolio Pulse from Benzinga Newsdesk
Stereotaxis has achieved CE Mark approval in Europe and submitted a 510(k) application to the FDA for its GenesisX Robotic System.
August 12, 2024 | 8:03 pm
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Stereotaxis has received CE Mark approval in Europe and submitted a 510(k) application to the FDA for its GenesisX Robotic System, potentially expanding its market reach and boosting sales.
The CE Mark approval allows Stereotaxis to market the GenesisX Robotic System in Europe, potentially increasing sales. The 510(k) submission to the FDA indicates progress towards US market entry, which could further boost revenue.
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