FDA Grants PMA-S Approval for Obalon Touch Inflation System

Medical Device Investing

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 …

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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