US Food and Drug Administration (FDA) 510(k) granted for SomnoDent MAS™

Following on from the very successful launch of the SomnoDent MAS™ in the US recently, the US Food and Drug Administration (FDA) today granted approval for SomnoMed to market and sell their device, indicated for the treatment of snoring and sleep apnea, in the US.

Jonathan C. Wright PhD, SomnoMed’s CEO, said: “This is a great result. The FDA 510(k) clearance was a significant operational hurdle for the company and now opens the door for SomnoMed to the enter the largest sleep market in the world; one that is at least five years ahead of the Australian domestic market both in terms of the level of awareness and understanding of both snoring and obstructive sleep apnea and the role of mandibular advancement devices in managing these conditions. Additionally, the fact that FDA approval was granted so quickly vindicates the decision to invest in a rigorously implemented quality system.” 

Dr Wright continued: “I extend my thanks and congratulations to the SomnoMed staff who worked so hard for this positive outcome and look forward to the challenges of moving forward with our global operations.”  

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