Xhale Assurance announced today that it has received CE Mark approval for its Nasal Alar SpO2 Sensor which allows for nasal ala oximetry utilizing a highly dependable central site.
GAINESVILLE, FL August 21, 2015 – Xhale Assurance, Inc.
Xhale Assurance, Inc. today announced it has received CE Mark approval of its Nasal Alar SpO2 Sensor for clinical use in CE countries. A CE Mark verifies the Assurance® Nasal Alar SpO2™ Sensor has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland.
“In light of the tremendous market response the sensor has already experienced in the U.S., we are excited to bring the Assurance® Nasal Alar SpO2™ Sensor to CE countries,” said John Moscarillo, Vice President at Xhale Assurance. “We are dedicated to meeting the growing demand for accurate, real-time pulse oximetry. With high European demand for the product, and now with CE Mark approval, we can report the shipment of our product to new customers in Europe.”
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 firstname.lastname@example.org for an invitation to the event.
For ordering information or to receive additional product information, contact your local distributor or contact Xhale toll-free at (855) 743-4589 or email@example.com.
- Comparative Desaturation Study performed at Xhale Assurance, Inc. and University of Florida, 2012. Data on file at Xhale Assurance, Inc.
- Melker, RJ, et al. Usability/Acceptance Study Final Report Xhale Assurance Nasal Alar Sensor. Feb. 2015. Data on file at Xhale Assurance.
- Morey TE, et al. Feasibility and accuracy of nasal alar pulse oximetry. British Journal of Anesthesia. Advance Access published April 15, 2014.
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 SpO2™ Sensor, received marketing clearance in the United States and has received CE Mark approval. The Assurance® Nasal Alar SpO2™ Sensor pulse oximetry sensor 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.
For more information, please visit www.xhale.com/assurance or contact the company at firstname.lastname@example.org.