GE Healthcare's AI-Powered Cardiovascular Ultrasound System Vivid Ultra Edition Receives FDA Approval to Reduce Exam Time

On October 16, Yiou Big Health learned that GE Healthcare recently announced that its Vivid Ultra Edition cardiovascular ultrasound system had received approval from the U.S. FDA. The system enables clinicians to perform rapid and repeatable examinations.

In echocardiography, systematic assessment of cardiac function is crucial. The accuracy of the examination depends on the quality of data acquisition and the technical proficiency of the operator.

Vivid Ultra Edition primarily leverages AI-driven, neural network-based algorithms to semi-automatically detect intravascular blood flow and velocity measurements. Meanwhile, it identifies the transducer angle used by the technologist and annotates each image accordingly.

According to GE Healthcare, the system reduces clicks by 80%, boasts 99% accuracy, and features lower operational complexity. Through the combined effect of these capabilities, the Vivid Ultra Edition helps physicians save approximately 7–10 minutes per scan.

“Vivid Ultra Edition helps healthcare professionals address two key challenges: the time-consuming nature of examinations and variability in quantitative results,” said Dagfinn Saetre, Cardiovascular Ultrasound Manager at GE Healthcare, in a statement.

In fact, to meet the demand for cardiac testing in COVID-19 patients, the FDA approved the first AI-assisted cardiac ultrasound acquisition system—Caption Guidance by Caption Health—in February this year. This is also Caption Health’s first commercialized product, and the software is applicable for cardiac ultrasound examinations or two-dimensional transthoracic echocardiography in adult patients. Subsequently, in May, the FDA intensively approved a batch of AI ultrasound devices, including those from Philips and Eko. Among these, the FDA also granted an Emergency Use Authorization (EUA) to Eko, given that its ECG-based algorithm can screen for signs of progressive heart failure in patients.

Previously, GE Healthcare also launched Edison HealthLink (a telemedicine system), which is designed to help physicians organize health data from clinical settings to enable rapid response to certain conditions, such as stroke treatment. The company stated that Edison HealthLink’s computing technology can evaluate brain scan data and provide timely feedback without the need to upload data to the cloud.

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