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BioWorld - Wednesday, May 27, 2026
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Home » Feops Heartguide granted FDA de novo authorization for LAAo planning
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Feops Heartguide granted FDA de novo authorization for LAAo planning

Oct. 15, 2021
By Catherine Longworth
Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows.
Medical technology Regulatory Software Digital health Cardiovascular De novo FDA

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