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Royal Philips Gets 510(k) Clearance for Heart Valve Repair AI Software From US FDA
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Royal Philips Gets 510(k) Clearance for Heart Valve Repair AI Software From US FDA
Mar 26, 2026 7:13 AM

09:47 AM EDT, 03/26/2026 (MT Newswires) -- 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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