In the News

Mass Device – FDA clears Nonin Medical flagship product

By Chris Newmarker July 8, 2020

Republished from Mass Device

Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product — the CO-Pilot wireless handheld multi-parameter system.

The handheld, wireless CO-Pilot is meant to make it easier for EMS, firefighters and military personnel to measure a person’s key vital signs following a cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation, and more.

The CO-Pilot is able to simultaneously track patient pulse oximetry (SpO2), pulse rate, carboxyhemoblin (COHb) and methemoglobin (MetHb) — with an additional sensor providing cerebral and tissue oximetry (rSO2).

“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 Dr. Guillaume Debaty of Grenoble Alpes University Hospital and SAMU de l’Isère in Grenoble, France.

“We also believe the technology has great potential for the management of cardiac arrest patients,” Debaty said in a news release.
Nonin Medical CEO Dave Hemink described the CO-Pilot as “another Nonin industry first that leverages wireless technology to give first responders potentially life-saving patient data to decide on treatment options during the golden hour.”