Enrollment completed across 18 clinical sites with 40+ investigators in the US, Canada, and New Zealand If the GPX ...
To establish feasibility before finalizing a device's design To capture data relating to safety and efficacy on near-final or final device design to plan for a critical study To facilitate the study ...
PMA, and DeNovo submissions to bring medical devices to the US market. Recent 510(k) modifications for new technologies and safety advancements, along with AI integration, present significant ...
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