Entries by Mark Tanner

Xhale Assurance Announces FDA Approval for Pediatric Indication for the Nasal Alar Sp02 Sensor

GAINESVILLE, FL August 31, 2017 – Xhale Assurance, Inc. Xhale Assurance, Inc. announced it has received FDA approval for its Nasal Alar Sp02 Sensor for use on patients at least 4 years old and weighing at least 15kg who are well or poorly perfused.  This is in response to clinician demand at children’s hospitals for […]

Xhale submits Biomarker Qualification package to FDA for Medication Adherence Monitoring Tool

Xhale submits Biomarker Qualification package to FDA for Medication Adherence Monitoring Tool. Gainesville, FL, September 21, 2015 Xhale, Inc. announced today that it has submitted to the Food and Drug Administration (FDA) the first Biomarker Qualification package for a Drug Development Tool for medication adherence monitoring.   The submittal to FDA marks an important step […]

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 […]