FDA Approves Comprehensive Lung Analysis Software
VIDA Diagnostics Inc. announced today that its primary product, Pulmonary Workstation 2.0 (PW2) has obtained FDA 510(k) clearance for sale.
PW2 is the first commercial release of lung image analysis software from VIDA and comprises a comprehensive approach to quantitative, repeatable lung measurements including the industry's first so-approved automatic lobe density and airway system measurement functions.
"We are privileged to be given the opportunity to make our leading PW2 application available to assist in the evaluation of millions of chronic obstructive pulmonary disease (COPD) and emphysema patients throughout the U.S.," said John Garber, VIDA CEO. "Since these diseases often affect specific regions of the lung, the ability to individually and objectively measure each of the five lobes and 25 major airways should fast become an invaluable complement to existing systemic measures like pulmonary function tests."
VIDA's PW2 takes the complex information from a CT (computed tomography) scan of the lung and converts it into useful 3D images and measurements that are easily viewed by the practicing pulmonologist at the point of patient service, or by the radiologist in the radiology department.
PW2 features include a number of lung or lobe volume and density measurements, an extensive named airway map and a full suite of measurement tools for each airway. For the first time, airway, lung, and lobe measurement tools are combined with advanced airway visualization to aid in patient assessment and procedure planning.
"With installations at 27 top research sites processing over 10,000 CT scans in the last three years, PW2 has proven to be a very reliable software package," said Juerg Tschirren, VIDA Vice President of Engineering. "After extensive validation and testing, we are pleased to release our software, Pulmonary Workstation 2.0, for clinical use."