Fortimedix Surgical news

510(k) Submission with FDA for FMX314 Surgical Platform

“We are very pleased to announce our submission with the FDA, as it represents an important milestone towards market introduction of FMX314 in the United States, which is expected in the fourth quarter of this year,” commented Mr. Marc van de Graaf, VP Global Business Development for Fortimedix Surgical.

FMX314 is the world’s first single-port surgery solution that is compatible with a standard 15mm laparoscopic trocar, promising fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis. Closely mimicking conventional, multi-port laparoscopy makes FMX314 easy to use and enables surgeons to perform procedural steps ergonomically, allowing for a comfortable and secure single-port approach.

“With its unique sizing and ease-of-use, we believe FMX314 will deliver on the promise of single-port surgery, elevating the standard of care in laparoscopy,” said Mr. Van de Graaf.

Note: FMX314 is the engineering code name for symphonX™ used during the pre-commercial phase.

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