GE Healthcare secures FDA clearance for cardiovascular system

13 October 2020 (Last Updated October 13th, 2020 12:25)

GE Healthcare has secured 510k clearance from the Food and Drug Administration (FDA) for its Ultra Edition package of Vivid cardiovascular ultrasound systems.

GE Healthcare secures FDA clearance for cardiovascular system
A methodical evaluation of heart function is considered vital in echocardiography. Credit: Patrick J Lynch, medical illustrator.

GE Healthcare has secured 510k clearance from the Food and Drug Administration (FDA) for its Ultra Edition package of Vivid cardiovascular ultrasound systems.

The Vivid Ultra Edition includes new features based on artificial intelligence (AI) to enable clinicians to obtain quick and more repeatable exams with consistency.

It delivers improved efficiency to the scanning process by providing reduced exam time through up to 80% fewer clicks, 99% accuracy and lower inter-operator variability.

A methodical evaluation of heart function is considered vital in echocardiography while high-quality data acquisition and operator skills are important elements to obtain accurate and complete exams.

Utilising AI-driven, neural network-based algorithms, Vivid Ultra Edition features enable repeatable and faster measurements in 2D echo imaging.

These include the ability to semi-automatically identify the required measurement of spectral Doppler images and finding the relevant points in the image used to derive vital measurements of the left ventricle.

Additionally, the AI-based view recognition feature enables the system to automatically detect which standard 2D scan plane is acquired and store the label in the image file.

GE Healthcare Cardiovascular Ultrasound general manager Dagfinn Saetre said: “With the Vivid Ultra Edition, we offer AI capabilities that help address healthcare providers’ two key challenges in echo exams – how time-consuming the exam is and the degree of variability that exists in the quantitative results.

“This package supports our vision of where we need to go with cardiovascular ultrasound: tools to support less variability and improved productivity. The Vivid Ultra Edition is a solid step in our strategic roadmap.”

In June, GE Healthcare rolled out a suite of eight artificial intelligence algorithms that analyse chest X-ray findings to help alleviate clinical strain, resulting from Covid-19.