Aerocrine, a medical products company, has announced that Japanese health authorities have approved the use of its FeNO-measuring device NIOX MINO as a tool for assessing patients with airway inflammation such as asthma.
On 19 November 2013, the Japanese Pharmaceuticals and Medical Devices Agency's (PMDA) granted Aerocrine regulatory approval for the 2009 version of its NIOX MINO.
This opens up for marketing and sales of Aerocrine's FeNO (fractional exhaled nitric oxide)-measuring device in Japan and also means that Japanese physicians can now receive reimbursement for FeNO tests.
Aerocrine Asian commercial director Tobias Bergenblad said: "The PMDA's approval is another milestone for the company because NIOX MINO is now the only approved FeNO-measuring device in Japan and it provides substantial clinical and quality assurance information for the users."
On 28 March 2013, PMDA approved the previous 2008 version of NIOX MINO, but sales could not increase as the older version of the device had already been discontinued from Aerocrine's product portfolio.
The now approved 2009 version of NIOX MINO is already in stock and ready for sales through Aerocrine's Japanese partner and exclusive distributor Chest M.I.
Aerocrine's NIOX MINO measures fractional exhaled nitric oxide (FeNO)-levels, which are higher in people with asthma than in other people. It was Aerocrine's founders who first discovered the link between FeNO and asthma caused by airway inflammation.
Today, Aerocrine is the world leader in FeNO measurement and the only device manufacturer with a global presence and FDA clearance for devices to be used for clinical practice.
