Obalon Announces FDA Approval of Obalon Navigation System

- December 21st, 2018

Obalon Therapeutics (NASDAQ:OBLN), a vertically integrated medical technology company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of the Obalon Navigation System, which eliminates the need to use x-ray when placing the … Continued

Obalon Therapeutics (NASDAQ:OBLN), a vertically integrated medical technology company with the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of the Obalon Navigation System, which eliminates the need to use x-ray when placing the Obalon Balloon System.

As quoted in the press release:

“We’re very pleased about the approval of the Obalon Navigation System which is intended to make placement of the Obalon Balloon more reliable, more convenient and more accessible to physician providers and patients by eliminating the costs and logistics related to acquiring x-ray” commented Kelly Huang, Ph.D., President and Chief Operating Officer of Obalon.  “I’d like to recognize the FDA for their timely review of the Obalon Navigation System, as well as the Touch Inflation Dispenser which was previously approved in the third quarter of 2018.  We believe Navigation and Touch provide another step forward in helping physicians and patients battle the obesity epidemic.”

The Obalon Navigation System utilizes magnetic resonance, rather than x-ray radiation, to image the Obalon Balloon during placement and displays a dynamic, real-time image of the Balloon on a notebook computer screen.  The Obalon Navigation System will be utilized in conjunction with the new, automated Touch Inflation Dispenser, and together they are intended to make placement of the Obalon Balloon more reliable, safer, easier and less expensive.

Click here to read the full press release.

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