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Medical Devices / Submissions and Approvals

FDA Clears Soft Tissue Visualization Addon for MRIdian SmartVision

Feb. 25, 2019

The FDA granted 510(k) clearance for ViewRay’s MRIdian SmartVision system, giving the go-ahead for the device’s new soft tissue visualization capabilities.

The addon for the SmartVision MRI — which allows for high-definition imaging while removing risks of skin toxicities — gives enhanced contrast between different tissues to help clinicians with tissue visualization.

The new clearance enables the system to give faster, brighter and more detailed imaging for more precise targeting of tumors.

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