Ventilation monitoring company Respiratory Motion Inc revealed on Thursday that it has passed the US FDA's clearance for the latest version of its ExSpiron Minute Ventilation (MV) monitoring system in pediatric population.
Following the US FDA's approval on on 16 March 2018, the company intends to launch the new ExSpiron at the Society for Pediatric Anesthesia-American Academy of Pediatrics in Phoenix, 23-25 March 2018.
The company said the ExSpiron is the first and only continuous Minute Ventilation Monitor that has been cleared for broad use in hospital and ancillary medical settings. It has previously been used across a variety of medical environments, providing real time, point-of-care data to improve the care and hospital experience of adult patients. It is the first and only MV monitor capable of providing continuous, non-invasive measurements for individuals not on a ventilator.
Unlike other respiratory monitoring technologies, the ExSpiron's extremely low false alarm rate (even with the aggressive motion seen in children), the device is positioned to help caregivers in their quest to achieve both patient safety and patient (and family) satisfaction, stated the company.
According to the company, a clinical study reported by Dr Viviane Nasr and colleagues from Children's Hospital of Boston in December 2017 in the prominent medical journal Anesthesia and Analgesia, laid the groundwork for US FDA clearance of the ExSpiron for use in children one year of age and older.
Pfizer reports positive Phase 3 data for ABRYSVO in adults at risk for RSV disease
D3 Bio announces Series A+ Round completion to advance innovative oncology pipeline
Dizal's sunvozertinib receives US FDA Breakthrough Therapy Designation
Merck launches Phase 3 trial of MK-1084 and KEYTRUDA combination in metastatic NSCLC
Trevi Therapeutics names new vice president of Clinical Development
Personalis validates NeXT Personal test for ultra-sensitive MRD detection
Merck reports lung cancer trial failed to meet endpoints
BerGenBio ASA starts Phase 2a portion of BGBC016 clinical study of bemcentinib