Cardiology

FEops HEARTguide Simulation Application

Feops NV

FDA
FDA-cleared AI medical device

An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

FDA Submission Metadata

Submission number
K250635
Decision date
November 2025
FDA panel
Cardiovascular
Product code
QQI

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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Regulatory Approvals

FDA
US FDA 510k

K250635

This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.