Israeli device company Medigus Ltd. has announced that it has received FDA 510(k) clearance for its SRS endoscopic system, designed for minimally-invasive endoluminal treatment of Gastro-oesophageal reflux disease (GERD/GORD).
Gastro-oesophageal Reflux disease has been in the news on this site recently with the news that Covidien’s Halo range of ablation products for the treatment of Barrett’s Oesophagus was expanding. Indeed, earlier this year we reported on Torax Medical’s announcement that its Linx, another device intended to reduce reflux, had gained FDA panel support and was likely to gain full approval.
Now an Israeli company, Medigus has announced that its SRS endoscopic system has gained FDA clearance. The SRS endoscope is inserted into the oesophagus through the mouth and does not entail incisions into the abdominal cavity. The endoscope contains a miniature video camera, ultrasonic sights, and a stapling device that enables the operator to perform partial fundoplication.
The device was cleared for marketing by the U.S. FDA via the 510(k) pathway, having successfully met safety and efficacy criteria during a multi-centre clinical trial in five countries and three continents. In addition to the FDA clearance, Medigus already possesses a CE mark for the SRS system.
Source: Medigus Ltd., PR Newswire