The Israeli Ministry of Health has granted an approval to Medigus for registering its SRS system, which is designed to treat gastroesophageal reflux disease, in the Israeli Register of Medical Equipment and Accessories (MEA).
The SRS system is reportedly the minimally invasive surgical treatment currently considered as the ‘gold standard’ for patients with severe gastroesophageal reflux disease.
The company already received CE mark approval in Europe, the US Food and Drug Administration and Health Canada marketing clearance for the SRS system, and expects that the MEA approval would help in receiving approvals in other countries, including State Food and Drug Administration (SFDA) in China.
Medigus CEO Elazar Sonenschein noted the Israeli market is an important and advanced market that is continuously pursuing technological innovations in the various fields of medicine, and is looking to adopt advanced treatments that meet high standards of efficacy and safety.
"We expect the MEA approval to assist us in advancing the process of receiving SFDA approval for marketing the system in China," Sonenschein added.
Medigus is currently in the initial stages of marketing its SRS system independently and through distributors in the US and Europe, and has already entered into a distribution agreement with the Chinese firm Sinopharm.