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FDA Greenlights First-Of-Its-Kind Heart Software

The authorization means that similar technology, known as interventional cardiovascular implant simulation software, can be cleared for market via the 510(k) pathway in the future. 

3d illustration Anatomy of Human Heart - Illustration

The US Food and Drug Administration has granted de novo authorization to the FEops HEARTguide, which is meant to simulate how a heart transplant will perform inside a patient.

The product can now be marketed as a class II interventional cardiovascular implant simulation software device.

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