Philips Receives FDA Approval for Its Latest Mini 3D TEE Transducer

Royal Philips has received the US FDA 510(k) clearance of its X11-4t Mini 3D transesophageal echocardiography (TEE) ultrasound transducer which is designed to serve more patients with improved overall comfort.

Developed to be easily tolerated by patients due to its 35% smaller size and pill-shaped design, Philips’ new X11-4t aims to enhance the patient experience, with 87% of clinical respondents stating they believe the X11-4t may contribute to improved overall patient comfort. Clinical staff can also benefit from a Mini Live 3D TEE solution that allows them to care for a wider range of patients, using the same hand control, procedure navigation techniques and workflow they are familiar with on Philips’ EPIQ cardiac ultrasound systems. As a result, echocardiographers require minimal additional training on this newest transducer.

The new transducer is compatible with Philips’ premium cardiology ultrasound portfolio including the EPIQ CVx and EchoNavigator image-guided therapy solution, allowing clinicians to deliver personalized, efficient, and clinically smart cardiac care to help improve outcomes and the patient experience. It also joins a portfolio that includes another significant innovation – VeriSight Pro – the first 3D intracardiac echocardiography catheter to miniaturize the same 3D imaging technology that powers TEE.

The Philips X11-4t ultrasound transducer is scheduled for commercial availability in 2024 and is pending CE mark in Europe.

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