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Aerocrine receives FDA marketing approval for Niox Vero

Sweden-based medical products company Aerocrine has received marketing approval from the US Food and Drug Administration for its device, Niox Vero.

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The device has been developed for measuring Fractional exhaled Nitric Oxide (FeNO) levels in the clinical setting.

Aerocrine CEO Scott Myers said: The portability and patient-centered improvements provided by Noix Vero will make it more practical for specialists as well as primary care physicians to make FeNO testing a routine part of identifying and managing allergic airway inflammation in patients with diagnosed or suspected asthma."

Niox Vero is a point-of-care device, which provides a patient’s FeNO score in about one minute after a simple 10-second exhalation.

Featuring rechargeable battery for portability within the clinical setting and an integrated visual display, the device is an enahnced version over the previous generation Niox Mino.

Both the devices play an important role in more effective diagnosis, treatment and follow-up of patients with inflammatory airway diseases such as asthma.

The company plans to launch Niox Vero in the first quarter of 2015.

According to the company, Niox Mino and Niox Vero are the only FeNO measurement devices cleared by the FDA and commercially available in the US.

Aerocrine chief medical officer Kathleen Rickard said: "FeNO testing is an important addition to clinicians’ tool set because it is the only way to objectively identify and manage allergic airway inflammation, which is the leading cause of asthma symptoms."


Image: Aerocrine CEO Scott Myers. Photo: courtesy of Aerocrine AB.