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Product approval

FDA approves navigation system for the Obalon Balloon

Eliminates the need for X-ray when placing the Obalon swallowable, gas-filled balloon

Obalon Therapeutics, has received approval from the FDA of the Obalon Navigation System, which eliminates the need to use x-ray when placing the Obalon Balloon System. The Obalon Navigation System utilises magnetic resonance, rather than x-ray radiation, to image the Obalon Balloon during placement and displays a dynamic, real-time image of the Balloon on a notebook computer screen. 

“We’re very pleased about the approval of the Obalon Navigation System which is intended to make placement of the Obalon Balloon more reliable, more convenient and more accessible to physician providers and patients by eliminating the costs and logistics related to acquiring x-ray,” said Dr Kelly Huang, President and Chief Operating Officer of Obalon. “I’d like to recognise the FDA for their timely review of the Obalon Navigation System, as well as the Touch Inflation Dispenser which was previously approved in the third quarter of 2018. We believe Navigation and Touch provide another step forward in helping physicians and patients battle the obesity epidemic.”

The Obalon Navigation System will be utilised in conjunction with the new, automated Touch Inflation Dispenser, and together they are intended to make placement of the Obalon Balloon more reliable, safer, easier and less expensive.

“We participated in the clinical trial for the Obalon Navigation System with the Touch Inflation Dispenser and were very impressed with the new technology to make placement of the Obalon Balloon more reliable, safer and easier,” stated Dr Mickey Seger, founder of BMI of Texas Bariatric Medical Institute in San Antonio, Texas.  “We especially appreciated the Obalon Navigation System’s dynamic 3D display during balloon placement, as opposed to the static 2D x-ray images we currently use.  The automated Touch Inflation Dispenser eliminates many of the connections and valves from prior dispenser, which should reduce the potential for error during balloon placement and inflation.”

The company expects to make the Obalon Navigation System and Touch Inflation Dispenser commercially available during the first quarter of 2019 in the US.

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