We are extremely proud to share the news that FEops HEARTguide™ received De Novo authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion with the Boston Scientific WATCHMAN™ device. FEops HEARTguide™ will enable physicians to virtually model clinical scenarios with different implant positions and sizes of the WATCHMAN™ device helping the heart team to select the optimal size and position for every individual patient. This De Novo is only a first step and we are already preparing for FDA 510(k) submission for FEops HEARTguide™ LAAo workflow with Abbott’s Amplatzer™ Amulet™ device and Boston Scientific’s WATCHMAN FLX™ device.”

More information here in the Press Release

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