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Medical Devices / Submissions and Approvals

Siemens Healthineers Receives FDA Clearance for MRI Application

Feb. 26, 2018

Siemens Healthineers received FDA clearance for GOKnee3D, a magnetic resonance imaging application used for diagnostic exams of the knee.

The device enables a push-button diagnostic 3D knee exam in 10 minutes. Acquisition of high-resolution isotropic 3D images enables flexible evaluation of the images in all planes.

The device is available for the MAGNETOM Aera 1.5T and the MAGNETOM Skyra 3T MRI scanners, with eventual rollout planned for additional scanners in the company’s MRI portfolio.

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