Qure.ai has announced that its AI-enabled Chest X-ray solution for Pneumothorax and Pleural Effusion has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Image courtesy: Qure.ai
September 12, 2023 — Medical imaging Artificial Intelligence (AI) company Qure.ai has announced a pivotal 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI-enabled chest X-ray solution — qXR, under two critical findings. Qure’s qXR has now been cleared to triage pneumothorax (PTX) and pleural effusion (PE), which present severe challenges in emergency rooms and intensive care units (ICUs), according to the company statement released today. The newest clearance is an addition to Qure’s existing FDA-cleared product portfolio that includes qXR-BT for breathing tube placement, qER for emergency room head CT scans, and qER-Quant for head CT quantification software.
The company reported that qXR has shown exemplary clinical accuracy in triaging pneumothorax (PTX), a condition where air collects in the pleural space, causing the lung to collapse. On the other hand, Pleura Effusion (PE) is where fluid accumulates in the pleural cavity. Performance evaluations reveal that qXR-PTX-PE excels in providing rapid passive notifications, taking an average of 10 seconds to alert healthcare professionals. This impressive speed positions qXR-PTX-PE as an indispensable medical tool designed to inform specialists promptly, especially in critical settings like ICUs and emergency rooms, and to complement the expertise of our trained medical professionals. Utilizing a globally sourced training dataset, qXR integrates into the existing standard of care workflow and serves as a passive notification system for worklist prioritization.
A multicenter publication, “Performance of a Chest Radiography AI Algorithm for Detection of Missed or Mislabeled Findings: A Multicenter Study,” was published (1) in an open access journal MDPI, where research focused on missed and mislabeled chest radiography findings, including pneumothoraces and pleural effusions, Subba R. Digumarthy, MD, a senior co-author of the study and thoracic radiologist at Massachusetts General Hospital (Boston, MA), reported up to 96% sensitivity and 100% specificity for the qXR algorithm.
“Speaking to physicians and hospital CEOs, we have heard the increasing need to reduce time to diagnosis." said Prashant Warier, CEO and Co-Founder of Qure. The FDA clearance of the qXR algorithm further demonstrates Qure’s commitment to addressing these challenges by optimizing healthcare delivery in time-sensitive settings like the ICU and ER.”
Neil Roy, MD, MBA, FACEP, CPE; Chief Medical Officer, Adventist Health Care Shady Grove Medical Center, offered this on the solution: “As an Emergency Medicine Physician, I have 4 to 5 patients undergoing various imaging studies at any time. The AI's ability to rapidly triage pneumothorax dramatically improves my speed and efficiency by alerting me to critical pathology far before a radiologist, or I personally have time to review the film. As a Chief Medical Officer, rapid pneumothorax identification adds a layer of safety to the hospital by providing a check to identify one of the most time-sensitive radiographic findings quickly.”
In its September 12 announcement, the company noted that the latest FDA clearance for qXR substantiates Qure's commitment to refining healthcare standards in the United States. Reporting that it was designed to integrate seamlessly into current healthcare pathways, the company also offered that qXR can improve ICU & ER workflows, furthering Qure’s mission to expedite and enhance patient care, noted the statement released by the company, founded in 2016, with offices in New York, London and Mumbai.
For more information: www.qure.ai
Reference:
https://www.mdpi.com/2075-4418/12/9/2086
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