Fda grants de novo marketing authorization to apollo endosurgery for apollo esg(tm) and apollo revise(tm), new endoscopic systems for patients with obesity

Systems offer effective, minimally invasive treatment options for millions of patients with obesity (bmi 30-50 kg/m2) austin, tx / accesswire / july 13, 2022 / apollo endosurgery, inc. ("apollo") (nasdaq:apen), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today the marketing authorization of the apollo esgtm, apollo esg sxtm, apollo revisetm and apollo revise sxtm systems through the u.s. food and drug administration's (fda) de novo classification process, a rigorous pre-market review pathway for low-to moderate-risk devices without a predicate. these are the first and only devices authorized by the fda for endoscopic sleeve gastroplasty (esg) and endoscopic bariatric revision.
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