Aerocrine Receives U.S. FDA Market Clearance for Niox Vero

Swedish devicemaker Aerocrine said it has received FDA clearance for its Niox Vero, a device used to measure fractional exhaled nitric oxide (FeNO) levels in patients with diagnosed or suspected asthma. It plans to launch the device in the first quarter of next year.

FeNO testing is the only way to objectively identify and manage allergic airway inflammation, which is the leading cause of asthma symptoms, said Kathleen Rickard, Chief Medical Officer at Aerocrine.  Testing for FeNO helps clinicians find hidden and under-treated allergic airway inflammation, which can help reduce asthma exacerbations by up to 50 percent, she added.

Niox Vero is a small, point-of-care device that delivers a patient’s FeNO score in about one minute after a simple 10-second exhalation, the devicemaker said. It includes a rechargeable battery which allows for portability and a visual display that helps patients execute a successful exhale.

The Niox Vero and the company’s previous generation Niox Mino are the only FeNO measurement devices approved by the FDA and available in the U.S. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.