• New minimally-invasive Laparoscopic surgery device given FDA approval


    Amsterdam: Netherlands-based Fortimedix Surgical said it had been granted US Food and Drug Administration (FDA) 510(k) clearance for its FMX314 single-port port system for minimally-invasive abdominal laparoscopic surgery. A 510(k) clearance means that the device has been proven safe and effective when compared with other already approved similar devices or systems, and can be marketed in the US. According to the company’s website, the FMX314 is “the world’s 1st single-port surgery solution compatible with standard 15mm laparoscopic trocar,” and reduces complications and post-operative pain by minimizing the size of the surgical opening. The device is expected to be introduced in mid-October.


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