Navigation Links
Assurance Biosense, Inc. Receives FDA 510(k) Clearance
Date:4/17/2013

Glastonbury, CT (PRWEB) April 17, 2013

Assurance Biosense Receives FDA 510(k) Clearance to Market Alar Sensor
-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.

For more information, please visit http://www.assurancebio.com or contact Investor Relations at the company at ir(at)xhale(dot)com or 352.371.8488.

Read the full story at http://www.prweb.com/releases/2013/4/prweb10640692.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Chemical Publishing Company; Author Colin Frayne of Aquassurance Inc. To Conduct Service Technician Training Course
2. UCSB professor receives award for graphene electronics research
3. Watsons Generic Yaz(R) Receives FDA Approval
4. Quanterix Receives Funding From the Department of Homeland Security to Develop Test for Botulinum Toxin
5. Life Technologies Ion Personal Genome Machine Receives San Diegos CONNECT Most Innovative New Product Award
6. MacroGenics Receives Milestone Payment as Part of Its Global DART™ Alliance with Boehringer Ingelheim
7. Intimate Bridge 2 Conception, Inc. Receives $4.3M
8. Pacific Meso Center Receives Generous Donation to First Free-Standing Mesothelioma Research Laboratory in Los Angeles
9. BioNeutral Group Receives $400,000 in Equity Financing
10. Amsterdam Molecular Therapeutics Receives US Orphan Designation for Hemophilia B Gene Therapy
11. Arcion Receives Notice of Allowance for US Patent for Novel Topical Lidocaine Formulation for Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... 23, 2016 , ... ClinCapture, the only free validated electronic ... showcase its product’s latest features from June 26 to June 30, 2016 for ... Disrupting Clinical Trials in The Cloud during the conference. DIA (Drug Information ...
(Date:6/23/2016)... ... June 23, 2016 , ... Velocity Products, a division ... tuned and optimized exclusively for Okuma CNC machining centers at The International Manufacturing ... collaboration among several companies with expertise in toolholding, cutting tools, machining dynamics and ...
(Date:6/23/2016)... , June 23, 2016 ... research report to its pharmaceuticals section with historic ... details and much more. Complete report ... 151 pages, profiling 15 companies and supported with ... http://www.reportsnreports.com/reports/601420-global-cell-culture-media-industry-2016-market-research-report.html . The Global ...
(Date:6/22/2016)... , June 22, 2016 Research and ... Global Markets" report to their offering. ... billion in 2014 from $29.3 billion in 2013. The market is ... of 13.8% from 2015 to 2020, increasing from $50.6 billion in ... projected product forecasts during the forecast period (2015 to 2020) are ...
Breaking Biology Technology:
(Date:4/28/2016)... , April 28, 2016 First quarter 2016: ... up 966% compared with the first quarter of 2015 ... SEK 589.1 M (loss: 18.8) and the operating margin was 40% ... 0.32) Cash flow from operations was SEK 249.9 M ... revenue guidance is unchanged, SEK 7,000-8,500 M. The operating ...
(Date:4/26/2016)... , April 27, 2016 ... the  "Global Multi-modal Biometrics Market 2016-2020"  report to ... ) , The analysts forecast the ... CAGR of 15.49% during the period 2016-2020.  ... number of sectors such as the healthcare, BFSI, ...
(Date:4/15/2016)... , April 15, 2016  A new ... make more accurate underwriting decisions in a fraction ... timely, competitively priced and high-value life insurance policies ... screenings. With Force Diagnostics, rapid testing ... lifestyle data readings (blood pressure, weight, pulse, BMI, ...
Breaking Biology News(10 mins):