FDA Grants PMA-S Approval for Obalon Touch Inflation System

- September 26th, 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 approval of a Premarket Approval Supplement (PMA-S) application for the Obalon Touch™ Inflation System from the United States Food and Drug Administration (FDA). As quoted in the press release: 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 approval of a Premarket Approval Supplement (PMA-S) application for the Obalon Touch™ Inflation System from the United States Food and Drug Administration (FDA).

As quoted in the press release:

The Obalon Touch Inflation System is an automated system utilized to inflate the Obalon Balloon.

“We are pleased to have received FDA approval of The Obalon Touch™  Inflation System,” said Amy VandenBerg, Vice President of Clinical and Regulatory Affairs. “Our near-term product pipeline is dedicated to further improving safety, reliability and ease of use of the Obalon Balloon System.”

The Obalon Touch is intended to be commercialized in combination with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement. A PMA-S application for the Obalon Navigation System was filed with the FDA in the third quarter of 2018 and is pending a decision by the FDA.

Click here to read the full press release.

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