The EasyOne Pro and Easy One Pro LAB mobile pulmonary function testing (PFT) devices have received Pharmaceuticals and Medical Devices Agency (PMDA) regulatory approval in Japan.
The ndd Medical Technologies, Inc. point-of-service mobile PFT devices are the first ones okayed in Japan, according to the company.
The lightweight devices measuring 12x12x12 inches can be deployed closer to patients in hospitals, clinics, mobile or remote screening locations.
Japan represents a potentially large market for the devices, according to ndd, since there are relatively few plethysmography-based hospital PFT labs, which are still common in U.S. and European hospitals. The ultrasound technology administers commonly required tests at a moment’s notice where and when needed, unlike many legacy systems that require calibration, preparation and upkeep.
The units allow “switch on, measure, switch off” operation to identify and manage people 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 mobile 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.
The EasyOne Pro performs single breath diffusing capacity for carbon monoxide (DLCO) testing, spirometry and full lung volumes in about 20 minutes. DLCO testing is commonly used to differentiate between asthma and chronic obstructive pulmonary disease, as well as to evaluate cardiovascular symptoms.
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 and lung clearance index measurements that determine the capacity of the lungs to keep small airways open and perform critical gas exchange functions.
The PMDA is a Japanese governmental organization similar in function to the U.S. Food and Drug Administration.