Medical products company Aerocrine has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its Niox Vero as a tool to assess patients with allergic airway inflammation such as asthma.
The device is said to measure Fractional Nitric Oxide (FeNO) levels in clinical settings.
Aerocrine CEO Scott Myers said: "With Niox Vero, we improved the usability compared to our previous product, Niox Mino, by including a more ergonomic design with a handle to exhale into, an integrated visual display to help patients complete the test and rechargeable battery for portability.
"The Niox Vero also has a long life span with up to five years of use and can manage up to 15 000 tests."
The company plans to introduce the device in the Japanese market in the second quarter of this year.
The device also received FDA approval in the US in November 2014, while CE mark approval in the EU in September 2013.
Aerocrine noted that Niox Mino and Niox Vero are the only FeNO measuring devices approved by both the PMDA in Japan and FDA in the US.
Aerocrine and Panasonic Healthcare have jointly developed Niox Vero. Both the firms entered a deal to develop products for airway inflammation monitoring for both clinical and personal use.
Under the deal, Panasonic will take the responsibility for manufacturing and supply of the devices and filters across the globe, while Aerocrine will take care of regulatory approvals, method development and global commercialization.