Qure.ai's AI-Enabled Chest X-Ray Solution qXR Receives FDA Clearance for Critical Conditions

The clearance expands Qure's existing FDA-cleared product lineup, including qXR-BT for breathing tube placement, qER for emergency room head CT scans, and qER-Quant for head CT quantification software.

Qure.ai, a Mumbai-based medical imaging AI company, has received FDA 510(k) clearance for its qXR chest x-ray solution.

The solution is capable of triaging pneumothorax (PTX) and pleural effusion (PE), both posing formidable challenges in emergency medical settings.

The clearance expands Qure's existing FDA-cleared product lineup, including qXR-BT for breathing tube placement, qER for emergency room head CT scans, and qER-Quant for head CT quantification software.

In addressing pneumothorax, a condition characterised by air accumulation in the pleural space causing lung collapse, qXR has exhibited notable clinical accuracy. Conversely, pleural effusion involves fluid buildup in the pleural cavity. Performance assessments confirm that qXR-PTX-PE stands out for its rapid passive notifications, taking an average of 10 seconds to alert healthcare professionals. 

This rapid response positions qXR-PTX-PE as an indispensable tool for informing specialists swiftly, especially in critical settings like intensive care units (ICUs) and emergency rooms. It complements the expertise of trained medical professionals by integrating into the standard workflow, serving as a passive notification system for prioritising worklists.

A multicenter study, including assessments of missed and mislabeled chest radiography findings, including pneumothoraces and pleural effusions, conducted by Dr. Subba R. Digumarthy, a senior coauthor of the study and thoracic radiologist at Massachusetts General Hospital, reported up to 96% sensitivity and 100% specificity for the qXR algorithm.

Dr. Neil Roy, MD, MBA, FACEP, CPE, chief medical officer at Shady Grove Medical Centre, highlighted the AI's role in dramatically improving the speed and efficiency of diagnosing pneumothorax. He emphasised that rapid identification adds a layer of safety to hospitals by quickly identifying critical pathology.

Prashant Warier, CEO and cofounder of Qure, acknowledged the pressing need to reduce the time to diagnosis in healthcare. He expressed how the FDA clearance of the qXR algorithm demonstrates Qure's commitment to addressing these challenges by optimising healthcare delivery, particularly in time-sensitive settings like ICUs and emergency rooms.

Founded in 2016 by Prashant Warier, who serves as the CEO, Qure.ai has firmly established itself as a renowned global player in medical AI. Headquartered in India, the company operates through its offices in London and New York, and is present in over 70 countries.

Qure.ai's suite of certified medical imaging AI solutions includes various medical applications. These include the analysis of neurocritical trauma or stroke CTs, detecting musculoskeletal X-ray fractures, and identifying lung cancer, tuberculosis (TB), or heart failure through chest X-rays and CT scans. 

In a recent development, Qure.ai has forged a partnership with PATH India, supported by funding from Unitaid. This collaboration focuses on leveraging the power of AI-driven qXR software to enhance the screening processes for tuberculosis and COVID-19 in Maharashtra.