VIDA Diagnostics Inc., a University of Iowa Research Foundation licensee and UI Technology Innovation Center business incubator tenant, 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."
"The University of Iowa congratulates VIDA on this important milestone," remarked Tom Sharpe, associate vice president for economic development at the UI. "We are proud of VIDA's accomplishments as well as the unique medical imaging center of excellence at the university that was the early innovator of this important technology. And we're pleased that the infrastructure we have developed at UI to support early stage technology companies has contributed to VIDA's success."
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. For the first time, airway, lung, and lobe measurement tools are combined in the comprehensive PW2 software application. Other lung products from VIDA will be available shortly.
"PW2 has set the standard for lung image analysis in the pulmonary research community, with installations at 27 top research sites and has been used to process over 10,000 CT scans in the last three years," continued Garber.
"The capabilities of PW2, shown to be helpful in the clinical research environment, can now be extended into the broader clinical practice," stated Geoff McLennan, VIDA co-founder and professor of medicine and radiology at UI. "This bench- to-bedside research and development, undertaken at the University of Iowa, can therefore now be made available to the wider national and international community of medical practitioners and to the people they serve, the patients."