Obalon Therapeutics (NSDQ:OBLN) said today that it won FDA clearance for its Obalon Navigation system intended for use in placing the company’s Obalon Balloon system.
The newly cleared Obalon Navigation system uses magnetic resonance imaging during placement and displays a real-time image of the balloon, the San Diego-based company said. The system is intended for use alongside the automated Touch Inflation Dispenser to improve placement procedures.
“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. 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,” Dr. Mickey Seger of San Antonio’s Texas Bariatric Medical Institute said in a prepared statement.
Obalon said it expects to launch the newly cleared systems during the first quarter of next year.
“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. I’d like to recognize 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,” prez & CEO Kelly Huang said in a press release.
In September, Obalon said that it won approval from the FDA for a premarket approval supplement application for its Obalon Touch inflation system.
