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Medical Devices / Submissions and Approvals

FDA Grants Approval to Obalon Balloon System

Sept. 14, 2016
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Obalon Therapeutics has received approval from the FDA for its Obalon Balloon System, which is a nonsurgical and fully reversible device for weight loss. The Obalon Balloon System consists of a balloon folded inside a capsule that is swallowed by the patient, with no sedation or anesthesia required.

In the clinical trial, 387 patients across 15 U.S. clinical trial sites participated.  Approximately 65 percent of patients who received the device experienced clinically meaningful weight loss of at least 5 percent of their total body weight.

The Obalon Balloon System is expected to be available in early 2017 to physicians in the U.S. market. — Cynthia Jessup

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