A tool billed as “the world’s first and only 15mm single-port surgery solution” has achieved 501(k) clearance from the U.S. Food and Drug Administration (FDA), according to Fortimedix Surgical.
The FMX314 is compatible with a commonplace 15mm trocar, putting it on par with more familiar multi-port laparoscopy approaches. The manufacturer boasts of the device’s ease of use, suggesting it will lead to shorter learning curves for physicians and increased procedural efficiency. They also note the design of the device allows surgeons to “perform procedural steps ergonomically.”
Last summer, the journal Surgical Endoscopy published a study demonstrating the effectiveness of the FMX314 for cholecystectomies, and the device was shown to be feasible for the transanal approach of colorectal surgery in a presentation to the Society of Gastrointestinal and Endoscopic Surgeons (SAGES). It has similarly been safely utilized in an array of gynecological procedures.
The formal introduction of the FMX314 to the U.S. market is expected to occur during the American College of Surgeons’ annual Clinical Congress, taking place in mid-October.