The US Food and Drug Administration (FDA) has granted 510(k) clearance to SomnoMed's SomnoDent G2 technology.
SomnoDent G2 includes modular adjustment parts and features ‘Click to Fit’ design which provides controlled measurement of a patient’s G2 mandible splints position to treat obstructive sleep apnea (OSA).
SomnoMed CEO Ralf Barschow said, "With the innovative SomnoDent® G2 and Somnomed MATRx® both now FDA cleared we are able to offer state-of-the-art oral appliance treatment and diagnostic solutions for OSA patients never seen before."
The company said it is unveiling its SomnoDent G2 at the 21st Annual Meeting of the Academy of Dental Sleep Medicine and 26th Annual Meeting of the Associated Professional Sleep Society (APSS) from 7- 13 June 2012 in Boston, Massachusetts, US.
In addition to diagnostic solutions for OSA, SomnoMed provides treatment solutions for sleep-related breathing disorders including snoring and bruxism.