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Home » FDA clears Nonin Medical flagship product

FDA clears Nonin Medical flagship product

July 8, 2020 By Chris Newmarker

CO-Pilot wireless handheld multi-parameter system Nonin Medical
The CO-Pilot wireless handheld multi-parameter system [Image courtesy of Nonin Medical]
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.”

 

Filed Under: 510(k), Diagnostics, Digital Health, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Nonin Medical Inc.

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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