Fortimedix Surgical gets FDA 510(k) clearance for single-port surgical platform

30 August 2016 (Last Updated August 30th, 2016 18:30)

The Netherlands-based medical device company Fortimedix Surgical has received US Food and Drug Administration (FDA) 510(k) clearance for its single-port platform, FMX314, to be used for minimally invasive abdominal laparoscopic surgery.

The Netherlands-based medical device company Fortimedix Surgical has received US Food and Drug Administration (FDA) 510(k) clearance for its single-port platform, FMX314, to be used for minimally invasive abdominal laparoscopic surgery.

FMX314 is developed as a single-port surgery solution compatible with a standard 15mm laparoscopic trocar, with fewer port-site complications. It helps in reducing hospital readmission rates, while treating hernias and infections.

The procedure involves less incisions, which results in a faster recovery, and a reduction in the use of analgesics, thereby improving overall procedural efficiency.

"We are very pleased to announce we have secured 510(k) clearance for our platform."

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.”

Patients benefit from less post-operative pain, faster recovery rates, and less scarring.

The device, measuring 15mm, is easy to use and allows surgeons to conduct procedural steps in an ergonomic manner, while paving the way for a comfortable and secure single-port approach, based on the procedures of a conventional laparoscopy.

The company is expecting to release FMX314 in the US during the ensuing ACS Clinical Congress 2016 in Washington, DC.