4Dx Completes FDA Submission Documentation
FOR IMMEDIATE RELEASE
As of November 10, 2019, 4Dx is proud to announce that all documents required to support an FDA 510(k) application have been handed over to its agent for electronic submission.
After a tremendously successful clinical validation trial, 4Dx founder and CEO, Andreas Fouras, was very happy to announce the trial’s results, which showed that 4Dx’s core platform, XV Technology™ was superior to current modalities in detecting and locating the loss of lung function, either due to disease or side-effects of treatments.
The first commercial product within the XV Technology family being examined by the FDA is the 4Dx Ventilation Report. It is 4Dx’s first commercial offering to enter into global healthcare markets, with the intent to begin with market-entry in the U.S., China and Australia.
The 4Dx Ventilation Report is an interactive report that is a collection of unique 4Dx test results and outputs that provide highly detailed and unprecedented calculations of the lungs’ ventilation properties.
Each 4Dx output included in the Ventilation Report utilizes 4Dx’s XV Technology™, which is a state-of-the-art lung imaging platform that uniquely images the lungs’ motion, as opposed to their shape. In doing so, 4Dx’s software is able to take information gathered from a standard cinefluorography sequence and provide back four-dimensional analysis on regional ventilation deficiencies at all locations within the lungs, and at all stages of the breath cycle.
“We’re quite excited,” said Andreas, making the announcement today. “4Dx’s mission is to give doctors earlier detection of changes in lung function to help doctors diagnosis earlier, provide more sensitive treatment monitoring and deliver much better patient outcomes. And with our technology giving a complete and unprecedented picture of a patient’s lungs, we believe we’re doing just that.”
Andreas continued, “It’s a very exciting time for us currently. We think our moment has come now and we’re very proud to announce that all the required documentation is in and our regulatory agent is electronically submitting our application .”
With the average timeframe for FDA approval being 112 days for Class II medical devices, 4Dx is hoping for regulatory clearance sometime in 2020.
4Dx is an innovative software company delivering a new gold standard in respiratory function analysis. The revolutionary four-dimensional technology accurately scans lung function and pulmonary ventilation as the patient breathes, working in combination with traditional x-Ray or CT imaging. The 4Dx technology provides greater sensitivity, resolution and accuracy for respiratory disease quantification and management over the current stand-alone imaging modalities. Our Software-as-a-Service scans enable more comprehensive results by identifying the subtlest variations in lung function while using lower levels of radiation than traditional methods.
Respiratory disease diagnosis and monitoring is a $30 billion p.a. global industry that 4Dx is aiming to disrupt and grow through imaging analysis technology that provides clinicians with greater insight into diseases of the lung. 4Dx will bring about a step change in lung health by providing better information to doctors and patients.
Better information = better decisions = improved patient outcomes