Obalon Therapeutics, a company that makes swallowable, gas-filled intragastric balloons that are an option over bariatric surgeries, won FDA approval for the Obalon Touch automated inflation system. The new product is used to inflate the Obalon Balloon and is going to be made available along with the new Obalon Navigation System (pending FDA approval), an offering that makes X-rays unnecessary during placement of the 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.”
Link: Obalon balloon system info page…
Via: Obalon…