Aerocrine’s Niox Vero device gets FDA marketing clearance

9 November 2014 (Last Updated November 9th, 2014 18:30)

Swedish medical products company Aerocrine has received marketing approval from US Food and Drug Administration (FDA) for its new device Niox Vero.

Swedish medical products company Aerocrine has received marketing approval from US Food and Drug Administration (FDA) for its new device Niox Vero.

The point-of-care device is designed to measure fractional exhaled nitric oxide (FeNO) levels in the clinical setting, and offers a patient's FeNO score in one minute after a simple 10-second exhalation.

Aerocrine CEO Scott Myers said: "The portability and patient-centred 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."

Featuring a rechargeable battery for portability within the clinical setting and an integrated visual display, Niox Vero is an improvement compared to Niox Mino.

"Niox Vero is designed to measure fractional exhaled nitric oxide (FeNO) levels in the clinical setting, and offers a patient's FeNO score in one minute after a simple 10-second exhalation."

Both devices play a major role in more effective diagnosis, treatment and follow-up of patients with inflammatory airway diseases including asthma.

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

According to Aerocrine, 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.

"Routine FeNO testing helps clinicians find hidden and under-treated allergic airway inflammation, which has been shown to help reduce asthma exacerbations by up to 50% compared to usual care."

Asthma is one of the most common diseases in the US, affecting between 8-10% of the population, and accounts for 90 million patient interactions with healthcare providers annually.