First Mobile PFT Devices to Receive Regulatory Approval in Japan
Andover, MA and Zurich, Switzerland—July 7, 2016—ndd Medical Technologies, Inc. announced that the company’s innovative EasyOne Pro® and Easy One Pro® LAB mobile devices, which perform comprehensive point-of-service pulmonary function testing (PFT), have received PMDA regulatory approval in Japan. They are the first mobile PFT devices in Japan.
The lightweight EasyOne devices measuring just 12 x 12 x 12 inches can be deployed anywhere they are needed– closer to patients either in hospitals, clinics, mobile or remote screening locations.
“Our devices are ideal for the potentially large Japanese market, which is unique in that there are relatively few plethysmography-based hospital PFT labs, which are still common in U.S. and European hospitals,” says Jürg Anderauer, ndd Medical’s Vice President of Sales. “Our accurate and maintenance-free ultrasound technology quickly administers all commonly required tests at a moment’s notice where and when needed, unlike legacy systems that require calibration, preparation and upkeep. The ndd system’s reliability and stability allows ‘switch on, measure, switch off’ operation to identify and best manage the people in Japan with lung diseases due to smoking, exposure to toxins or certain medications known to cause respiratory symptoms.”
In the U.S., some hospitals are also replacing aging and far costlier PFT labs with the EasyOne Pro ultrasound-based devices, which require no service contracts or disposables other than inexpensive mouthpieces.
The mobile devices enable hospitals to perform efficient bedside or office PFTs for any symptomatic patients, regardless of presenting diagnosis, with the goal of identifying COPD at an earlier stage when it can be treated and arrested.
DLCOtesting determines cause of shortness of breath
The EasyOne Pro performs single breath Diffusion Capacity (DLCO) testing, spirometry and full lung volumes in just 20 minutes. DLCO testing is commonly used to differentiate between asthma and COPD, as well as to evaluate cardiovascular symptoms.
EasyOne Pro LAB for complex respiratory testing
The EasyOne Pro LAB offers all the testing capabilities of the EasyOne Pro plus multiple-breath nitrogen washout to obtain complete lung volumes, Functional Residual Capacity (FRC) and Lung Clearance Index (LCI) measurements that determine the capacity of the lungs to keep small airways open and perform critical gas exchange functions.