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:10/2/2017)... Fla. , Oct. 2, 2017  AllianceRx Walgreens ... company formed by Walgreens and pharmacy benefit manager Prime ... its new brand, which included the unveiling of new ... , as well as at a few other ... the new brand to patients, some of whom will ...
(Date:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation announce a ... sensors for real-time monitoring of patients with trauma-related and ... focused on disruptive health solutions for rare disorders and ... record and integrate behavioral, cognitive, physiological and contextual data. ... ...
(Date:9/25/2017)... R.I. , Sept. 25, 2017  EpiVax, ... assessment, vaccine design, and immune-engineering today announced the ... on the development of personalized therapeutic cancer vaccines. ... has provided exclusive access to enabling technologies to ... Eng., MBA will lead EpiVax Oncology as Chief ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of Family ... next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his retirement. ... 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming the ...
(Date:10/13/2017)... CT (PRWEB) , ... October 13, 2017 , ... ... long-term care services, staged a mock evacuation of the facility as part of a ... Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as ...
(Date:10/13/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... and least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints ... for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance (FHC), ... will showcase a range of technology and learning solutions at the 68th Annual ... Expo to be held October 14–18, 2017 at the Mandalay Bay Resort in ...
(Date:10/12/2017)... , ... October 12, 2017 , ... The American College ... to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in ... , In honor of Morris F. Collen, a pioneer in the field of medical ...
Breaking Medicine News(10 mins):