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FDA Clears GE’s Cardiac Spectral CT

FDA Clears GE’s Cardiac Spectral CT

GE Healthcare’s cardiac spectral CT has received FDA 510(k) clearance, the company announced. The Discovery CT750 HD Freedom Edition addresses challenges in cardiac imaging such as coronary motion, calcium booming, plaque composition and accurate myocardial perfusion, the company said.

The system provides the following features: Motion Freedom with motion correction via SnapShot Freeze, which helps reduce cardiac motion by detecting vessel motion and velocity to determine the position and correct the effects of motion; Calcium Freedom with enhanced coronary visualization using Gemstone Spectra Imaging Cardiac; and Horizon Free, which provides plaque material composition assessment and accurate perfusion calculations.

The HD Freedom Edition’s first U.S. installation was at the University of Washington, Seattle, and is available in about two dozen locations in Europe and Japan, where physicians are using SnapShot Freeze and GSI Cardiac in routine practice for coronary evaluation.

According to GE, the system leads the industry in cardiac CT spatial resolution at 18.2 lp/cm, which helps physicians accurately quantify stenoses in coronary vessels by displaying reduction in calcium blooming compared to standard resolution.

Disclosures

 
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