Qure.ai has received a crucial 510(k) FDA approval for their AI-driven chest X-ray tool, qXR, which is especially designed for triaging pneumothorax (PTX) and pleural effusion (PE), both of which are difficult conditions to treat in ERs and ICUs.

This approval broadens Qure's FDA-cleared product portfolio, which already includes qXR-BT for tube installation, qER for head CT scans, and qER-Quant for CT quantification.

qXR exhibits clinical accuracy in PTX assessment, where air collects in the pleural space, and in PE, characterized by pleural cavity fluid buildup. Performance assessments reveal qXR-PTX-PE’s exceptional speed, with an average alert time of just 10 seconds for healthcare professionals.

Neil Roy, MD, MBA, FACEP, CPE; Chief Medical Officer, Shady Grove Medical Center said,

“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.”

“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.”