SomnoMed Receives 510(K) Clearance for SomnoDent Fusion
SomnoMed Limited has announced that it has received FDA 510(k) clearance from the US Department of Health & Human Services for its new SomnoDent Fusion Classic and SomnoDent Fusion Flex oral devices.
The new designs were introduced at the American Academy of Dental Sleep Medicine (AADSM) and American Academy of Sleep Medicine (AASM) conventions in Minneapolis at the beginning of June and received positive customer reactions.
The SomnoDent Fusion is a patented design, which allows greater range of calibration. It has exchangeable wings, which makes adjustments of the forward position of the SomnoDent device easier for the practitioner and patient.
“We believe that SomnoDent Fusion represents another step forward in strengthening SomnoMed’s global leadership position in COAT TM (Continuous Open Airway Therapy) for obstructive sleep apnea,” said Dr. Peter Neustadt, Chairman and CEO of SomnoMed. “SomnoDent Fusion offers improvements over existing devices and a greater level of patient comfort. Patient comfort is at the center of SomnoMed’s mission and product philosophy, as it has a direct impact on compliance. We believe the more comfortable the treatment, the more compliant the patient, which is a precondition for better medical treatment outcome. The high level of compliance is giving COAT a distinct advantage over CPAP for the majority of patients.”
The product will be commercially available in the next few months.