Oventus receives FDA clearance for O2Vent W

By LabOnline Staff
Friday, 14 July, 2017

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.

Related News

Single-cell sequencing system tackles kidney research

Monash University scientists have adopted a Single Cell RNA-Seq System, from Dolomite Bio, to...

Avita Medical and BARDA execute a US$24.3m contract option

Regenerative medicine company Avita Medical has announced the execution of an expanded contract...

Paradigm receives ethics approval for osteoarthritis trial

Paradigm Biopharmaceuticals has received ethics approval for its Phase 2b clinical trial to...

  • All content Copyright © 2017 Westwick-Farrow Pty Ltd