FDA grants de novo clearance for endoscopic sleeve gastroplasty, bariatric revision devices

The FDA has granted de novo authorization for Apollo Endosurgery to market its Apollo ESG and Apollo REVISE endoscopic systems for the treatment of patients with obesity, according to a company press release.These are the first devices authorized by the FDA for endoscopic sleeve gastroplasty and endoscopic bariatric revision procedures.“Obesity affects 108 million adults in the United States and is growing in prevalence year over year; only a small fraction (approximately 0.2%) are treated with bariatric surgery,” Chas McKhann, president and CEO of Apollo, told Healio. “NewRead More

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