SomnoMed’s Sleep Apnea Device Gains FDA 510(k) Clearance

June 25, 2015

SomnoMed has won FDA marketing clearance for its oral device SomnoDent with micro-recording technology for mild to moderate obstructive sleep apnea, the Australian devicemaker said Tuesday.

The product is meant to be worn while sleeping and provides continuous open airway therapy by positioning the jaw slightly forward, which tightens the upper airway soft tissue and muscles. This helps prevent a collapse of the airway and reduces sleep apnea, the company says.

In addition, the micro-recording feature allows medical professionals to track patient compliance.

The company expects to launch the device soon. — Jason Scott