SomnoMed Limited (ASX:SOM) has received FDA 510(k) approval from the U.S. Department of Health & Human Services for its sleep apnea devices, allowing it to start sales in July.
The approvals were received for its new SomnoDent® Fusion Classic and SomnoDent® Fusion Flex oral appliances that were introduced at conventions at the beginning of June.
These have exchangeable wings, which makes adjustments of the forward position of the SomnoDent® device easier for the practitioner and patient.
Both products offer improvements over existing sleep apnea devices and a greater level of patient comfort.
The company’s products are already distributed throughout 16 countries in Europe, which represents 40% of its global sales.
Outlook for European sales volume and revenue growth in FY14/15 is strong.
News: SomnoMed Limited receives U.S. approval for sleep apnea devices
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