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Explore how early integration of toxicologic pathology can improve medical device safety, reduce miscommunication, and strengthen regulatory outcomes in device development.

The road to bringing a medical device to market is fraught with potential regulatory pitfalls and decisions that can delay—or even derail—your efforts.

The limitations of current PFO occluders According to the Mayo Clinic, approximately one in four people have a hole between the left and right chambers of the heart known as a patent foramen ovale, or PFO. First-generation PFO occluders were designed to stop any resulting blood flow between the two chambers.