FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears Coronary Artery Disease Intervention Planner

Sept. 16, 2019
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HeartFlow received 510(k) clearance for its Planner virtual modeling tool, a device used to create a model of a patient’s coronary arteries.

The Planner makes a color-coded 3D model, allowing physicians to mark areas of narrowing and look into multiple treatment routes by modifying the model.

Using the device, physicians can consult prior to the procedure and visualize the treatment path from anywhere a tablet can be used.

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