Free press releases distribution network?

Agency / Source: Xhale, Inc.

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!



Assurance Biosense Announces FDA 510k Clearance to Market Alar Sensor - Assurance Biosense Announces they have received FDA 510(k) Clearance to Market their Alar Sensors
Assurance Biosense Announces FDA 510k Clearance to Market Alar Sensor

 

PRZOOM - /newswire/ - Gainesville, FL, United States, 2013/04/16 - Assurance Biosense Announces they have received FDA 510(k) Clearance to Market their Alar Sensors.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

- Unique Nasal Ala Pulse Oximetry Sensor;
- Alar Sensing Promises High-Levels of Accuracy, Stability and Monitoring Reliability;
- Sensor Compatible with Large, Existing Installed Base of Pulse Oximeters.

Assurance Biosense, Inc., a subsidiary of Xhale, Inc., today announced receipt from the U.S. Food and Drug Administration (FDA) of 510(k) clearance to market its Assurance® Alar Sensor for monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients.

The nasal ala, the fleshy part of the nose adjacent to the opening of the nares (nostril), is a region rich in vasculature and offers a unique monitoring site for pulse oximetry. This site is fed by both the external and internal carotid arteries; the latter also provides blood to the brain. This multi-directional arterial supply provides strong, reliable photoplethysmography signals that are rapidly responsive to changes in the patient’s arterial oxygen saturation. This measurement site is less susceptible to patient movement or loss of signal due to variations in peripheral perfusion as are the extremities, and is easily accessed by an anesthesiologist during surgery.

The Assurance Alar Sensor is intended for the continuous non-invasive monitoring of SpO2 from the nasal ala of adult and pediatric patients (weighing >30kg). The single patient use sensor attaches comfortably to the nasal ala without the need for adhesives at the placement site and can easily be checked and moved by the clinician as necessary, allowing it to remain on the patient for the full length of stay. The sensor is compatible with the large installed base of monitors compatible with the Nellcor Oxisensor-II sensor.

Andrew E. Kersey, President of Assurance Biosense, stated,“We are excited to receive clearance to market our unique Assurance Alar Sensor. We plan to begin initial shipments to select customers over the coming weeks. This revolutionary new sensor offers the benefits of reliable central monitoring while using existing legacy pulse oximeters and at no additional cost to that of traditional disposable finger-tip based oximeter sensors.”

“Clinical testing has shown central monitoring of pulse oximetry to be an improvement over peripheral sites such as the finger-tips used by traditional sensors”, Mr. Kersey continued,“further improving the measurement of this vital sign and improving patient care. Compared to monitoring at the finger-tip, central pulse oximetry has been shown to offer reliable measurements during extremely low perfusion, as well as faster detection of desaturation and resaturation events particularly during low perfusion. The nose is an excellent site for ease of access during surgery, while the hands are not readily available to anesthesiologists. This first product in our portfolio will be an important foundation upon which we will add future products that capitalize on the benefits of measurement at the alar site.”

About Assurance Biosense
Assurance Biosense, a wholly owned subsidiary of Xhale, Inc., is committed to providing clinicians with easy to use, cost effective diagnostic solutions that improve patient safety and reduce false alarms. Its Assurance PPG/oximetry sensors monitor central blood flow to the brain through placement on the nasal ala, a region rich in vasculature, fed by the external and internal carotid arteries. The unique physiology of the site provides a much stronger signal than that from a fingertip or extremity, delivering more robust pulse oximetry signals, while simultaneously enabling the monitoring of a range of critical physiologic parameters which cannot be monitored via conventional pulse oximetry.

About Xhale
Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART®, the world’s only definitive medication adherence monitoring system, and Assurance®, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor more comfortably and conveniently, and with fewer false alarms, than finger-based pulse oximetry.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Agency / Source: Xhale, Inc.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick PRZOOM - Press & Newswire Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 
 
  Your Banner Ad showing on ALL
Medical Services/Equipment articles,
CATCH Visitors via Your Competitors Announcements!


Assurance Biosense Announces FDA 510k Clearance to Market Alar Sensor

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name PRZOOM - Press & Newswire and LINK as the source.
 
  For more information, please visit:
Is this your article? Activate ALL web links by Upgrading to Press Release PREMIUM Plan Now!
|
Contact: Richard Allen - Xhale.com 
352-371-8488 ir[.]xhale.com
 
PRZOOM / PRTODAY - Newswire Today disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Xhale, Inc. securities in any jurisdiction including any other companies listed or named in this release.

Medical Services/Equipment via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!




Read Latest Press Releases From Xhale, Inc. / Company Profile


Read Medical Services/Equipment Most Recent Related Press Releases:

Sparta Systems Broadens Partnership with TrackWise Implementation Specialist Equality Systems
Thales Launches the Pixium Portable 3543 DR Wifi Enabled Flat Panel Detector
GE Healthcare Showcases Industry-first Technologies and Digital Solutions, Focused on Improving Outcomes, At RSNA 2016
Agfa and LCsys Team Up to Launch ABSOLUT-ID, Their Turnkey Integrated Solution for the Production of High Security ID Cards
ZOLL Technology for Improving CPR Quality to be Showcased at American Heart Association Annual Conference
AccuVein to Exhibit Leading Vein Visualization Technology at American Society for Dermatologic Surgery Annual Meeting
US Biomedical Textiles Transform Implant Device Technology by Aligning to Changes in Patient Preference Finds Frost & Sullivan
Frost & Sullivan Commends Influence Health for Constantly Evolving its Patient Engagement Products to Accelerate Market Transformation
Frost & Sullivan Awards Carestream Top Honors for OnSight 3D Extremity System
Sparta Systems Launches the Next-Generation Cloud Solution Stratas QMS

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
 
NewswireToday Celebrates 10 Years in Business
Find business coaching, life coaching, executive coaching and corporate coaching, best selling coaching books, ...



PREMIUM Members


Visit  BizJobs.com

Visit  JobsWare.com

Visit  Triggr & Bloom







 
  ©2016 PRZOOM — Limelon Advertising, Co.
Home | About PRZOOM | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneur newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today