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Anaxsys files respiR8 counter device 510(k) application with FDA

Anaxsys has filed its respiR8 continuous respiratory rate counter's 510(k) premarket notification application with the US Food and Drug Administration (FDA) for regulatory clearance.

Electrochemical respiR8 device comprises a patented sensor pre-fitted into a standard oxygen mask, which is connected to a small electronic monitor that captures, displays and records continuous respiratory rate in the awake or sedated patients.

Anaxsys co-founder and managing director Deryk Williams said subject to clearance by the FDA, US healthcare professionals will be able to better monitor patient respiratory rate, which has been highlighted by the medical community as the vital sign which provides the earliest indication of patient deterioration in the post-operative period yet is the least monitored.

"Recent studies and publications in the U.S. by eminent physicians and patient safety organisations are calling for routine continuous monitoring of respiratory rate in order to improve patient safety and help reduce the incidence of post-operative drug induced respiratory depression, post-operative cognitive impairment (dementia) and cardiac arrests," Williams added.

"By continuously monitoring respiratory rate, respiR8 can alert healthcare professionals to patient deterioration from inadequate oxygenation, which has been shown to lead to significant post-operative delirium which can result in cognitive impairment and increased mortality, or potentially life threatening respiratory depression that can result in fatal respiratory arrest.

"respiR8 can also provide early warning signs of possible myocardial infarctions as it will alert healthcare professionals to patients’ rapid breathing – a symptom which can occur up to 45 minutes before cardiac arrest."