SomnoMed Receives 510(K) Clearance for SomnoDent® Fusion
July 09 2014 - 11:27AM
Business Wire
SomnoMed Limited (ASX:SOM) 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
COATTM (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.
About SomnoMed:
SomnoMed is the global leader in COATTM (Continuous Open Airway
Therapy) and provides clinically proven diagnostic and treatment
options for sleep-related breathing disorders such as obstructive
sleep apnea (OSA) and sleep bruxism. The company’s SomnoDent® is a
treatment solution that has proven effective for over 175,000
patients in 24 countries.
For additional information, visit SomnoMed at
http://www.somnomed.com.
MediaLine CommunicationsPaul Williams,
310/569-0023paul@medialinecommunications.com
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