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Home » Obalon Therapeutics wins FDA nod for Obalon Touch inflation system

Obalon Therapeutics wins FDA nod for Obalon Touch inflation system

September 28, 2018 By Fink Densford

Obalon Therapeutics

Obalon Therapeutics (NSDQ:OBLN) said this week it won approval from the FDA for a premarket approval supplement application for its Obalon Touch inflation system.

The newly cleared Obalon Touch is an automated system designed to inflate the Obalon balloon, a gas-filled balloon intended to promote weight loss in obese patients, the San Diego-based company said.

“We are pleased to have received FDA approval of the Obalon Touch inflation system. Our near-term product pipeline is dedicated to further improving safety, reliability and ease of use of the Obalon Balloon System,” clinical & regulatory affairs VP Amy VandenBerg said in a press release.

Obalon said that it plans to commercialize the Obalon Touch in combination with its Obalon navigation system, which is intended to eliminate the need for X-ray imaging during balloon placement. It added that it filed a PMA-S application for the navigation system during the third quarter of this year, and that it is currently pending a decision from the FDA.

Last month, Obalon Therapeutics saw shares rise after it closed a private placement that brought in gross proceeds of $10 million.

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Weight loss Tagged With: Obalon Therapeutics

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