Healthcare technology firm Spirometrix has secured CE mark approval for its Fenom PRO point-of-care breathalyzer to market in European countries.
Fenom PRO point-of-care breath analyzer is a portable and battery-operated device, which features a solid-state senor that uses an electrochemical reaction to yield a millivolt output.
Later, the output will be translated into nitric oxide (NO) levels by an algorithm.
The patient need to breath into the Fenom PRO device for about 10 seconds at the physician’s office or in the hospital.
Next, the device measures the NO content in the lungs, and provides a result in about 30 seconds.
The device will connect automatically to a cloud-based decision repository and support system, which will provide big data insights about the 250 million people worldwide who suffer from asthma.
Spirometrix CEO Dean Zikria said: “The entire Spirometrix team has been working very diligently to achieve this significant milestone, and we believe that receiving CE mark will maintain our strong momentum toward commercialization.
“The Fenom PRO point-of-care breathalyzer is the first-of-its-kind product in asthma that embraces several sensors and a digital ecosystem designed to effect documentation that may lead to enhanced clinical decision support.”
The company is also developing Fenom Home at-home breath analyzer to offer exhaled nitric oxide information to an asthmatic individual.
The device will use an electrochemical reaction to yield a millivolt output, which is then translated by an algorithm into exhaled nitric oxide (FeNO) levels.
Spirometix provides devices for the diagnosis and management of chronic diseases such as asthma, COPD, and chronic pulmonary hypertension.