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:10/12/2017)... , Oct. 12, 2017 West ... in innovative solutions for injectable drug administration, today announced ... the market opens on Thursday, October 26, 2017, and ... results and business expectations at 9:00 a.m. Eastern Time. ... or 253-336-8738 (International). The conference ID is 94093362. ...
(Date:10/11/2017)... 2017  True Health, a leader in integrated ... during National Breast Cancer Awareness month to educate ... Research recently published ... more than 10 million American women are at ... or BRCA2 and have not had testing. These mutations ...
(Date:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical ... innovative solutions for injectable drug administration, today shared the ... ID Adapter for improving the intradermal administration of polio ... Skin Vaccination Summit in May 2017 by Dr. ... Polio Department, World Health Organization (WHO), and recently published ...
Breaking Medicine Technology:
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... Mohebi Hair Restoration, has recently contributed a medical article to the newly revamped ... cosmetictown.com. Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular ...
(Date:10/12/2017)... Washington, D.C. (PRWEB) , ... October 12, 2017 , ... ... of their peers in Washington, D.C., for the 49th Congress of the International ... Ph.D ., Vice President of the Center for Cancer and Blood Disorders ...
(Date:10/12/2017)... Mich. (PRWEB) , ... October 12, 2017 , ... ... has been named one of Michigan’s 2017 Best and Brightest in Wellness® by ... Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to ...
(Date:10/12/2017)... ... October 12, 2017 , ... In ... taxes a year. In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, ... overseas retirement havens have extremely low property-tax rates, which contributes to the relatively ...
(Date:10/12/2017)... ... October 12, 2017 , ... Farm Forward ... and other leading institutions in announcing the launch of the Leadership Circle ... way animals are raised for food. , Founding members of the Leadership Circle ...
Breaking Medicine News(10 mins):