15 Nov 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 a cutting-edge medtech company aiming to deliver the new gold standard in respiratory imaging and ventilation analysis for all lung disorders – including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, and cancer.
The unique 4Dx technology is the first and only modality that images the motion of the lung tissue quickly, during the breath cycle – providing back quantitative regional measurements of ventilation with pinpoint accuracy at every location within the lungs, at each stage of the breath. Our platform operates with greater sensitivity than any other system to date, is non-invasive, operates using existing hospital equipment, requires no contrast agents, and delivers a radiation dose equal to about two chest X-rays.
4Dx’s Software-as-a-Service (SaaS) reports deliver quantifiable data on the subtlest variations in lung function down to the finest details, providing for earlier diagnosis and intervention, as well as the opportunity to closely monitor ventilation changes that occur over time due to progression of disease or effectiveness of treatment.
4Dx aims to provide clinicians with greater insights into lung disease, and thus bring about a step change in lung health by providing better information to doctors and patients that allows for better decisions and better patient outcomes.