Xhale Assurance Announces FDA Approval of its Second Generation Nasal Alar SpO2 Sensor

Xhale Assurance, Inc., developer of the patented Assurance® Nasal AlarSpO2TM Sensor, today announced FDA clearance and the global launch of its second-generation pulse oximetry sensor.

The new Assurance® Nasal AlarSpO2TM Sensor is now compatible with the majority of pulse oximetry monitors in use in a wide variety of health care settings.

“The Assurance® Nasal AlarSpO2TM is a true innovation in pulse oximetry,” says John Moscarillo, Vice President of Xhale Assurance. “This sensor provides dependable monitoring3 in a wide variety of patient conditions and settings, early detection of oxygen saturations changes1, and in a recent study, the sensor was validated for 7-days of continuous use which can provide substantial cost savings for the health care system2.”

The Assurance® Nasal Alar SpO2 Sensor is easily removed and reapplied, eliminating the waste associated with trying multiple sensors to get a good signal. And because it can be repositioned the nasal alar sensor can eliminate pressure injuries; unlike forehead sensors which contribute to tissue necrosis with prolonged use4.

“Because the Assurance® Nasal Alar SpO2 Sensor is placed at the nasal ala, it is unaffected by many of the most common conditions that cause inaccurate pulse oximetry readings,” reports Dr. Richard Melker, Chief Technology Officer of Xhale Assurance. “In research studies, Nasal Alar Oximetry™ detected desaturations up to 30 seconds faster than finger-applied sensors”1,5

Xhale Assurance will be presenting several webinars on the Assurance® Nasal Alar SpO2™ Sensor in the near future. If you are interested in attending a webinar, email info@xhale.com for an invitation to the event.

For ordering information or to receive additional product information, contact your local distributor or contact Xhale at 855.743.4589 or XA.CustomerService@xhale.com.

 

 

 

  1. Comparative Desaturation Study performed at Xhale Assurance, Inc. and University of Florida, 2012. Data on file at Xhale Assurance, Inc.
  2. Melker, RJ, et al. Usability/Acceptance Study Final Report Xhale Assurance Nasal Alar Sensor. Feb. 2015. Data on file at Xhale Assurance.
  3. Morey TE, et al. Feasibility and accuracy of nasal alar pulse oximetry. British Journal of Anesthesia. Advance Access published April 15, 2014.
  4. Lee M, Eisenkraft JB, Forehead pulse oximeter-associated pressure injury, A A Case Rep. 2014 Jan 15;2(2):13-5. doi: 10.1097/ACC.0b013e3182a66b29.
  5. Melker, RJ, et al. Earlier Detection of Desaturation NADIR from the Nasal Ala. Presented at the Annual Meeting of the Society for Technology in Anesthesia, January 2013

 About Xhale

 Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology designed to offer definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Through its Xhale Assurance, Inc. subsidiary, Xhale is developing a patient monitoring technology, the Assurance® platform, designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Nasal Alar SpO2TM pulse oximetry sensor, that received marketing clearance in the United States, is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

 

Xhale, Inc. was founded in 2005 on technology licensed from the University of Florida.