FDA Provides Clearance for GE's FREEdom Cardiac Imaging Platform

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The FDA has cleared GE Healthcare’s new cardiac imaging platform, the Discovery CT750 HD FREEdom Edition. According to the press release, the FREEdom Edition is designed to address the main challenges of cardiac imaging: coronary motion, calcium blooming, plaque composition and accurate myocardial perfusion.

Motion FREEdom and SnapShot Freeze technology accomplishes intelligent motion correction by determining actual vessel position and correcting the effects of motion during cardiac CT exams. Bench-top evaluation demonstrated that SnapShot Freeze can achieve a 58msec Equivalent Gantry Rotation Speed, which is 4 to 6 times faster than hardware-only gantry rotation speed alone. This translates to a 29msec Effective Temporal Resolution, achieving a Cardiac CT temporal sampling similar to the frame rate of a cath lab.

Calcium FREEdom technology enhances coronary visualization using Gemstone Spectral Imaging (GSI), making it possible to take coronary images with calcium suppression from patients with high calcium burden. Additionally, GSI Cardiac enables investigations into CT coronary plaque assessment and quantitative myocardial perfusion.

GE’s Discovery CT750 HD leads the industry in cardiac CT spatial resolution at 18.2 lp/cm^. This level of resolution helps physicians make a confident diagnosis and accurately quantify stenoses in coronary vessels by displaying reduction in calcium blooming compared to standard resolution.

The Discovery CT750 HD FREEdom Edition is the first Cardiac Spectral CT scanner that merges GE’s SnapShot Pulse technology with GSI’s fast kV switching allowing for a registered spectral CT dataset. Spectral CT can create images of quantitative material density, which can then be synthesized into monochromatic energies. Monochromatic images have key advantages in virtually beam-hardening artifact free images, and improved contrast-to-noise at a given dose.

FREEdom Edition is built on the Discovery CT750 HD platform. The system is powered by GE's exclusive HD and low dose technologies, including GSI for lesion characterization and Adaptive Statistical Iterative Reconstruction (ASiR) dose-optimizing technology already used on over 12 million scans at 1,200 sites worldwide.