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Home » FDA clears GE Healthcare AI-powered cardiovascular ultrasound system

FDA clears GE Healthcare AI-powered cardiovascular ultrasound system

October 13, 2020 By Sean Whooley

GE-Healthcare-logoGE Healthcare (NYSE:GE) announced that it received FDA 510(k) clearance for its Ultra Edition package on Vivid cardivascular ultrasound systems.

The Ultra Edition package on Vivid cardiovascular ultrasound systems includes new features that are based on artificial intelligence (AI) designed to enable clinicians to acquire faster, more repeatable exams on a consistent basis, according to a news release.

Vivid Ultra Edition reduces exam time through up to 80% fewer clicks, 99% accuracy and less inter-operator variability, the company said.

The AI features within the Vivid Ultra Edition includes automatic detection of the appropriate measurement of spectral Doppler images and relevant points in the image for deriving measurements of the left ventricle, along with view recognition for which standard 2D scan plane is acquired.

Other features include HD color displays, FlexiLight for improving visualizations and a 4D TTE pediatric probe for 2D and 4D imaging in pediatric patients ranging from neonates to teenagers.

“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,” GE Healthcare GM of cardiovascular ultrasound Dagfinn Saetre said in the release. “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.”

Filed Under: 510(k), Cardiovascular, Food & Drug Administration (FDA), Imaging, Regulatory/Compliance, Structural Heart, Ultrasound Tagged With: FDA, GE Healthcare

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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