BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

FDA Clears Breathe Technologies, Inc.'s Sleep System


5/30/2013 6:22:42 AM

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

Breathe Technologies Sleep System Receives FDA Clearance

IRVINE, Calif.
, May 30, 2013 /PRNewswire/ -- Breathe Technologies, Inc., a manufacturer of innovative medical devices for people with respiratory conditions today announced the Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its Sleep System (Continuous Positive Airway Pressure, or CPAP & Interface) in the US for treatment of Obstructive Sleep Apnea (OSA). The Breathe Sleep System utilizes miniaturized technologies coupled with user-centric design to provide a new therapeutic solution for patients with OSA.

"Reaching this milestone ahead of schedule is a testament to the expertise of our world-class team," said Larry Mastrovich, CEO of Breathe Technologies. "Our approach to respiratory care is centered on improving patients' quality of life. Based on extensive research with patients and clinicians, we have designed a clinically effective system with unique features."

Breathe's Sleep System is easy to set-up and provides effective CPAP therapy with a comfortable, discrete interface and tubing. Additional advanced features include a redesigned humidification system, an interactive patient touch-screen interface, and a smart pressure ramp function. Breathe Technologies product portfolio will be further enhanced with the addition of the Breathe Sleep System. Breathe Technologies' award-winning Non-Invasive OPEN Ventilation (NIOV) System is a one pound, wearable hospital to home miniaturized ventilation device that facilitates early ambulation in hospital settings and enables patient independence in the home for better quality of life. NIOV is currently in use by clinicians and patients across the country, including public and private hospitals, VA healthcare facilities, pulmonary rehab centers, and with patients at home.

For more information on Breathe Technologies' products visit www.breathetechnologies.com or contact us at info@breathetechnologies.com.

About Breathe Technologies, Inc.

Breathe Technologies, Inc., located in Irvine, California, is a developer and manufacturer of innovative medical technologies for treating respiratory conditions. The company was founded with the goal of transforming the lives of people with respiratory insufficiency by producing innovative therapies that have the potential to dramatically improve quality of life. The Breathe Non-Invasive OPEN Ventilation (NIOV) System, featuring the company's proprietary OPEN-airway platform, is FDA-cleared for use in both the institutional and homecare settings. The Company has received FDA clearance for its Sleep System to address unmet needs in sleep apnea. Breathe has taken an integrated approach focused on an improved user experience, supported by innovative design and best in class therapy. Investors include Kleiner Perkins Caufield & Byers, Delphi Ventures, Johnson & Johnson Development Corporation, Synergy Partners International, DAG Ventures and Morgan Creek. For more information, please visit www.breathetechnologies.com

SOURCE Breathe Technologies, Inc.



Help employers find you! Check out all the jobs and post your resume.

Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES