Koninklijke Philips N.V. (PHG) on Wednesday announced that the FDA has granted 510(k) clearance for its new X11-4t Mini 3D transesophageal echocardiography (TEE) transducer.
TEE provides detailed images of the heart and its internal structures, aiding cardiologists in minimally invasive heart surgeries and procedures.
The company's X11-4t is designed to be easily tolerated by patients due to its 35% smaller size and pill-shaped design, with 87% of clinical respondents believing it may improve overall patient comfort.
The company said that this new transducer is compatible with Philips' premium cardiology ultrasound portfolio, including the EPIQ CVx and EchoNavigator image-guided therapy solution.
The company stated commercial availability of the Philips X11-4t ultrasound transducer is scheduled for 2024, pending the CE mark in Europe.
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