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.
