FDA Clears Nonin Medical CO-Pilot Multi-Parameter System

Nonin Medical, Inc. today announced the CO-Pilot™ Wireless Handheld Multi- Parameter System (H500) received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The CO-Pilot is a handheld device with wireless capabilities that helps EMS, firefighters and military personnel measure patient parameters following cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.

The CO-Pilot offers reliable readings to allow for improved patient care in an ambulance, at the scene of a fire, or any emergency setting before arrival at a hospital.

The CO-Pilot simultaneously tracks patient pulse oximetry (SpO2), pulse rate, carboxyhemoblin (COHb) and methemoglobin (MetHb). Cerebral and tissue oximetry (rSO2) can be measured using an additional sensor.

“During our clinical study of the CO-Pilot (H500) we found it to be portable and extremely easy to use. The ability to track a multitude of parameters was beneficial and provided critical information for patient care,” said Guillaume Debaty, M.D., Ph.D., an emergency medicine physician at Grenoble Alpes University Hospital and the head of SAMU de l’Isère in Grenoble, France. “We also believe the technology has great potential for the management of cardiac arrest patients.”

One important feature of the CO-Pilot is the ability to measure brain and tissue oxygenation when administering CPR to patients who experience out-of-hospital cardiac arrest (OHCA). A study by the American Heart Association estimates that 326,200 OHCAs occur in the U.S. each year. On average 10.6% of people survive and 8.3% survive with good neurologic function.¹ The CO-Pilot provides tissue oximetry data to track decreases in tissue oxygenation, which is a critical metric for survival and brain function. In addition, the CO-Pilot can assist in the clinical assessment of carbon monoxide poisoning, allowing first responders to make treatment decisions at the scene or on the way to a hospital.