AEROCRINE AB RECEIVES FDA CLEARANCE FOR NIOX VERO® BLUETOOTH® WIRELESS ENHANCEMENT
SOLNA, Sweden – March 6, 2015– Aerocrine AB (Nasdaq Stockholm: AERO) announces today that clearance was received for its FeNO measuring device to operate wirelessly with BlueTooth® technology in the US.
The US FDA has granted Aerocrine AB regulatory clearance for NIOX VERO® through a special 510k to utilize BlueTooth® wireless technology to send FeNO measurements and patient data between the NIOX VERO and the healthcare providers’ computers. This cordless enhancement allows the device to go with a healthcare provider to a patient regardless of setting, either in an examination room, a pulmonary function lab or other setting. The clearance also allows the NIOX VERO to wirelessly transmit patient data to the computer for storage by the healthcare providers on the NIOX Patient software, Aerocrine’s propriety data repository or other electronic medical record software the healthcare providers may be using.
NIOX VERO® is the company’s next generation device for measuring Fractional Nitric Oxide (FeNO) levels in a clinical setting. This measurement has been found to be cost effective to aid in the diagnosis and management of allergic airway inflammation such as with asthma.
As of January 19th, Aerocrine, Inc. launched the NIOX VERO in the US market. This improved device will make it easier for physicians and patients to gain benefit from the use of FeNO measurement as part of their asthma diagnosis and management. The NIOX VERO is now completely portable should the customer choose to use it that way. The NIOX VERO’s battery can hold a full day charge and can be brought to the patient in the examining room instead of the patient having to go to the device.
For more information, contact:
Scott Myers, Chief Executive Officer, Aerocrine AB, Phone: +46 768 788 379, +1 970-368-0336
Kathy Rickard, Chief Medical Officer, Aerocrine AB, Phone: +1 919-749-6708
Aerocrine AB is a medical products company focused on improved management and care of patients with inflammatory airway diseases such as asthma. Within this sector, Aerocrine is the world leader. Aerocrine markets NIOX VERO® and NIOX MINO® which enables fast and reliable point-of-care measurement of airway inflammation. This product plays a critical role in more effective diagnosis, treatment and follow-up of patients affected with inflammatory airway diseases. Aerocrine is based in Sweden with subsidiaries in the US, Germany, Switzerland and the UK. Aerocrine shares have been listed on the Stockholm Stock Exchange since 2007. For more information please visit www.aerocrine.com and www.niox.com.