Amenity Health said today that its medical device, MedCline, won CE Mark approval in the EU.
The San Diego, Calif-based company manufactures a device called MedCline, which is a medical device scientifically proven to help alleviate chronic health issues such as GERD and acid reflux.
“We are pleased to announce the CE Mark approval of MedCline, signifying that we have completed the rigorous quality and performance requirements of the EU authorities,” said CEO Aaron Clark.
CE marking is the medical device manufacturer’s claim that a product meets the Essential Requirements of the Medical Device and all relevant European Health, Safety and Environmental Protection Legislation Product Directives.
The approval also represents a significant milestone towards the commercialization of MedCline and demonstrates the commitment we have to our existing and future customers, partners, and investors. We look forward to making MedCline available to patients throughout the World.
MedCline was founded in 2011 by Carl Melcher, M.D, who was a life-long sufferer of GERD. Dr. Melcher wanted to help the millions of GERD patients with a natural treatment alternative utilizing positional therapy. Since development, the Reflux Relief System has been validated in 7 clinical trials. Aiming to help other medical conditions with positional therapy, MedCline has also developed a Shoulder Relief System for those who suffer with chronic shoulder pain at night. Both MedCline Relief Systems are providing much-needed relief for those suffering from nocturnal acid reflux and/or nighttime shoulder pain to get quality, restorative sleep leading to a higher health-related quality of life.
