Aerocrine AB Receives FDA Clearance for NIOX VERO® BlueTooth® Wireless Enhancement
March 06 2015 - 02:24AM
Business Wire
Aerocrine AB (STO:AEROB) 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.
About Aerocrine
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.
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Aerocrine ABScott MyersChief Executive OfficerPhone:
+46 768 788 379+1 970-368-0336orKathy RickardChief
Medical OfficerPhone: +1 919-749-6708