FEops’ Pre-Operative HEARTguide Planner Gets FDA’s 510(k) Clearance

FEops has received the FDA’s 510(k) clearance for its HEARTguide pre-operative planner for left-atrial appendage occlusion procedures.

The software is intended for use with Abbott and Boston Scientific devices, according to the Ghent, Belgium-based company.

The cloud-based software allows physicians to virtually model clinical scenarios with different implant positions and sizes of the Abbott and Boston Scientific devices for left-atrial appendage occlusions, allowing them to select the optimal size and position for each patient.