4DMedical Ltd Receives FDA Clearance for Innovative CT:VQ Imaging Software
Melbourne-based 4DMedical Ltd, a software development company specializing in medical applications, has recently achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its groundbreaking CT:VQ™ imaging software. This development marks a pivotal advancement in the field of medical imaging, particularly in the assessment of lung health.
FDA Clearance for CT:VQ™
CT:VQ™ is the world’s first and only non-contrast, CT-based imaging technology that provides quantitative ventilation and perfusion analysis directly from standard chest CT scans. Traditionally, ventilation-perfusion scans required patients to inhale radiotracers and undergo imaging with a gamma camera, a process that could take up to 90 minutes and depended heavily on nuclear medicine infrastructure. The new CT:VQ™ technology eliminates these requirements, offering a faster, more efficient alternative.
The FDA clearance was announced on September 1, 2025, and was highlighted in multiple financial news sources, including Smallcaps.com.au and HotCopper.com.au. This clearance is expected to significantly enhance 4DMedical’s market position, particularly in the United States, where the company already serves a substantial customer base.
Market Reaction
The news of FDA clearance has positively impacted 4DMedical’s stock performance. On September 1, 2025, shares of 4DMedical were noted to be charging higher, alongside other companies such as Genesis Minerals, Harvey Norman, and RPMGlobal, as reported by Fool.com.au. This surge in stock price reflects investor confidence in the company’s innovative technology and its potential to capture a significant share of the medical imaging market.
Company Overview
4DMedical Ltd, listed on the ASX All Markets stock exchange, has a market capitalization of approximately AUD 237.43 million. Despite a negative price-to-earnings ratio of -4.73, the company’s recent achievements and strategic advancements suggest a promising future. The company’s headquarters are located in Melbourne, Australia, with additional operations in Los Angeles, California.
For more information about 4DMedical Ltd and its offerings, interested parties can visit their website at www.4dmedical.com . The company continues to focus on developing cutting-edge medical software solutions, aiming to improve patient care and streamline medical processes globally.