The US Food and Drug Administration (FDA) has granted 510(k) approval to Medigus's SRS endoscopic system.
The approval was based on a multi-center clinical trial which met a criteria of safety and efficacy in five countries and three continents.
The SRS endoscope featuring a miniature video camera, ultrasonic sights, and a stapling device is designed for minimally-invasive endoluminal treatment of gastroesophageal reflux disease (GERD).
The SRS endoscope is inserted into the esophagus through the mouth and does not entail incisions into the abdominal cavity.
The company has also received CE mark approval for the SRS system.
Source:
http://endoscopydevices.medicaldevices-business-review.com/news/fda-clears-medigus-srs-endoscopic-system-250512
