Fortimedix Surgical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new FMX314 single-port surgical platform.
The platform has been developed for use in minimally invasive abdominal laparoscopic surgery.
FMX314 is claimed to be world's first single-port surgery solution that is compatible with a standard 15mm laparoscopic trocar.
It results in fewer port-site complications and less post-operative pain, in addition to helping in better recovery and cosmesis.
The platform’s emulating conventional and multi-port laparoscopy features enable surgeons to carry out procedural steps ergonomically.
The company will commercially introduce FMX314 platform during the ACS Clinical Congress 2016 in Washington, DC, which is being held from 16 to 20 October.
In March, the company submitted a premarket notification for the FMX314 single-port surgical platform with the FDA.
Fortimedix Surgical CEO Wout Bijker said: "We are very pleased to announce we have secured 510(k) clearance for our platform, as it signifies an important milestone in our quest to deliver on the promise of single-port surgery.”
Based in Nuth of Netherlands, Fortimedix Surgical is engaged in the development of novel devices for single-port surgery.