The ECGenius™ System, Signal Complexity™, and PVI Analyzer™ are FDA cleared. The ECGenius™ System, Signal Complexity™, and PVI Analyzer™ are not approved for sale in the EU.
Fast Mapping™ is not FDA cleared or approved for sale in the EU.
This product has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 872902 – CathVision Cube.
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