Oventus receives FDA clearance for O2Vent W
Australian medical device company Oventus Medical has received FDA 510k clearance for its O2Vent W device, an oral appliance intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnoea (OSA).
With a US distribution partner recently signed, and appliances with the two most popular mandibular advancement mechanisms now cleared for sale, the company will focus on ramping up US sales.
Oventus Managing Director and Chief Executive Officer Neil Anderson said: “The O2Vent W is important to the company’s product plans and follows the recent signing of Modern Dental as a global distribution partner.
“We now have the right product mix and right distribution partner to accelerate our launch into the lucrative US market. First sales of the winged appliance are planned for this quarter, with ramp-up from next quarter,” he added.
Oventus will continue to expand its product range, noting that the Oventus Positive Airway Pressure (PAP) connection — currently in an advanced stage of development — will be compatible with the O2Vent W appliance for low-pressure combination therapy.
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