Royal Philips Receives FDA Approval For EchoNavigator R5.0 With DeviceGuide

Benzinga·03/26/2026 13:20:00

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Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for EchoNavigator R5.0 with DeviceGuide, an AI-powered software solution that assists physicians during one of interventional cardiology's most technically demanding procedures – repairing leaking mitral valves through a minimally invasive approach.

DeviceGuide was developed in close collaboration with Edwards Lifesciences, the global leader in structural heart innovation, aligning Philips' imaging and AI expertise with Edwards' expertise in valvular heart therapy development. Together, the companies have innovated image guidance of the mitral transcatheter edge-to-edge repair (M-TEER) workflow to make these complex minimally invasive heart valve repair procedures more intuitive and streamlined.

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