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Medigus gets FDA 510(k) clearance for next generation MUSE system

Medigus, an Israel-based medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its next generation MUSE system, designed to perform minimally invasive treatment of gastroesophageal reflux disease (GERD).

The MUSE system enables an incisionless procedure by performing an anterior partial fundoplication with standard surgical staples in a less invasive way.

The next generation MUSE, formerly known as the SRS system, is a single operator system that enables endoscopists to treat GERD by performing a fundoplication procedure through the mouth.

The procedure currently targets patients with symptomatic chronic gastroesophageal reflux disease or GERD, with a potential long-term solution aimed at restoring the esophageal anatomy with a minimally invasive tool in order to reduce or eliminate symptoms.

Medigus’ new MUSE system incorporates an improved graphical user interface and is easier to use.

The intuitive endosurgical platform consists of a single use surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder.

Medigus CEO Chris Rowland noted FDA clearance of the MUSE system is a significant milestone for the company and will allow patients in the US to have access to the most advanced technology for treating GERD.

"This is an important achievement in our 2014 strategic plan, and allows us to focus on the implementation of a scalable commercial, clinical and physician training model through the establishment of ‘centers of excellence’ in the US," Rowland added.