Navigation Links
SomnoDent®G2 FDA 510(k) cleared
Date:6/7/2012

FRISCO, Texas, June 7, 2012 /PRNewswire/ -- SomnoMed Limited (SOM:ASX) is pleased to announce that it has received a 510(k) from the US Food and Drug Administration ("FDA") and will now begin marketing its unique SomnoDent® G2 in the USA. The SomnoDent® G2 technology (patent pending) has been developed over several years, after extensive research and development, following US quality system requirements and the FDA regulatory process.

SomnoDent® G2 will be launched at the 21st Annual Meeting of the Academy of Dental Sleep Medicine and 26th Annual Meeting of the Associated Professional Sleep Society, LLC (APSS) from 7- 13 June 2012 in Boston.

SomnoDent® G2 incorporates modular adjustment parts, which are uniquely identified and provide instant and accurate advancement of the G2 splints. This revolutionary design "Click to Fit" will provide a controlled measurement of a patient's mandible position to treat OSA. The device's range of motion has also been extended providing more treatment options. The SomnoDent® G2 includes SomnoMed's proprietary materials, is metal free and is 20% smaller than SomnoMed's current range of sleep apnea devices, thereby increasing patient comfort.

SomnoDent® G2 will be available through qualified SomnoMed Preferred Dental Network partners only. A newly designed premium packaging and travel case will also protect the device when not in use. Accompanied by an adjustment kit, which stores and organizes the modular adjustment parts, the SomnoDent® G2 represents a new standard of care for Obstructive Sleep Apnea (OSA) patients.

"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," says CEO Ralf Barschow. "These revolutionary, premium product innovations continue our focus on evidence based, quality clinical outcomes for patients".

For more information please visit SomnoMed at www.somnomed.com or contact:
Ralf Barschow
CEO, SomnoMed Inc.
+1 888 447 6673 Ext. 101
Cell +1 972 742 2995

About SomnoMed
SomnoMed is a public company providing diagnostic and treatment solutions for Sleep-related Breathing Disorders including obstructive sleep apnea, snoring and bruxism.  SomnoMed was commercialized on the basis of extensive clinical research. Supporting independent clinical research, continuous innovation and instituting medical manufacturing standards has resulted in SomnoDent® becoming the state-of-the-art and clinically proven medical oral appliance therapy for obstructive sleep apnea. SomnoDent® is the most comfortable and effective design and treatment solution for over 100,000 patients in 22 countries.


'/>"/>
SOURCE SomnoMed
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. ViewRay Receives FDA 510(k) Clearance for MRI-Guided Radiation Therapy System
2. MAQUET Cardiovascular Receives FDA 510(k) Clearance For New Mega® Intra-Aortic Balloon Catheter Sizes
3. Angioslide Announces FDA 510(K) Clearance of PROTEUS(TM) Below The Knee Device
4. Nephros Receives 510(k) Clearance for Hemodiafiltration System
5. Cardium Exhibiting Its New FDA-Cleared Excellagen® At The 2012 Spring Symposium Of Advanced Wound Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... Calif. , Feb. 4, 2016  Edwards Lifesciences ... patient-focused innovations for structural heart disease and critical care ... accelerated share repurchase (ASR) agreement with Morgan Stanley & ... stock.  This repurchase is part of the Company,s previously ... the Company,s common stock.  --> ...
(Date:2/4/2016)... , Feb. 4, 2016 Wegener ... Global Markets Direct,s, ,Wegener Polyangiitis - Pipeline ... Wegener Polyangiitis,s therapeutic pipeline. This report provides ... Polyangiitis, complete with comparative analysis at various stages, ... (MoA), route of administration (RoA) and molecule type, ...
(Date:2/4/2016)... 2016  Omnicell, Inc. (NASDAQ: OMCL ), a leading ... systems, today announced results for its fiscal year and ... --> GAAP results: Revenue for the ... million or 4.1% from the third quarter of 2015, ... quarter of 2014. Revenue for the year ended December 31, ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... 05, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... Tasting Event at the La Gorce Country Club in Miami Beach on March ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Give ... allow users to search for and donate to Give To Cure’s campaign that is ... app that lets users make and share payments through a smart device. In 2015 ...
(Date:2/5/2016)... ... 2016 , ... Stuart Bentkover, MD, FACS is thrilled to announce ... most effective tattoo removal today, Dr. Bentkover is the only doctor in Central Massachusetts ... PicoSure has been approved by the Food and Drug Administration (FDA) as a safe ...
(Date:2/5/2016)... ... February 05, 2016 , ... California Mobile Kitchens ... debut of their latest mobile kitchen model, featuring customizable stainless steel interiors and ... commercial kitchens for use anywhere in the U.S. Many of their units can ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Susan ... Medicare San Luis Obispo users can expect to see in 2016. To view the ... most significant changes will directly impact many San Luis Obispo seniors who rely on ...
Breaking Medicine News(10 mins):