Royal Philips Gets 510(k) Clearance for Heart Valve Repair AI Software From US FDA
MT Newswires Live
Mar 26
Royal Philips (PHG) said Thursday it has obtained 510(k) clearance for its artificial intelligence-powered software EchoNavigator R5.0 with DeviceGuide from the US Food and Drug Administration.
DeviceGuide, which helps doctors in the repair of heart valves through a minimally invasive approach, was developed in collaboration with Edwards Lifesciences (EW), Royal Philips said.
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