Qure Achieves 6th FDA Clearance for Exclusive Chest X-ray Solutions Tailored for Radiologists, Pulmonologists, and ER Physicians
Qure.ai achieves its 13th FDA clearance with the qXR-LN AI chest X-ray solution, marking a significant milestone in AI-powered advancements for medical imaging. This is the 6th FDA clearance for Qure’s chest X-ray solutions, uniquely intended for Radiologists, Pulmonologists, and ER physicians. The qXR-LN presents a remarkable opportunity to enhance lung nodule detection, contributing to the fight against lung cancer.
qXR for Lung Nodule (qXR – LN) is a cutting-edge computer-aided detection software designed to identify and highlight regions indicative of suspected pulmonary nodules ranging from 6 to 30 mm in size. Tailored for use in the incidental adult population, this innovative device is a game-changer in diagnostic technology. It can also serve as a crucial second reader for physicians, assisting in the review of frontal (AP/PA) chest radiographs of adults acquired on digital radiographic systems.
“With this latest addition to our large series of recent FDA clearances, we are steadfast in our unwavering commitment to the US healthcare space.”
Prashant Warier, Co-Founder & CEO, Qure.ai
Prashant Warier, Co-Founder & CEO, Qure.ai, said, “With this latest addition to our large series of recent FDA clearances, we are steadfast in our unwavering commitment to the US healthcare space. Having already effectively deployed and implemented this solution globally, this clearance marks yet another ground-breaking leap in our pioneering efforts to combat lung cancer.”
Qure conducted two pivotal studies to establish the safety and efficacy of its lung nodule device. In the initial pivotal study, Qure successfully demonstrated standalone performance that met predefined success criteria, achieving an Area Under the Curve (AUC) of 94% for nodule detection. The study involved qXR-LN and included chest X-ray scans collected from 8 states and 40 individual sites across the United States. The device’s performance was assessed against the ground truth determined by five American board-certified Radiologists. These Radiologists interpreted Chest X-rays alongside corresponding CT scans and reports, with the ground truth based on nodules visible on the Chest X-ray.
In the second pivotal study, a landmark clinical evaluation of qXR-LN was conducted through a multi-reader, multi-case clinical validation study. The performance of various readers, including radiologists, pulmonologists, and emergency room physicians, showed improvement. The qXR-LN algorithm demonstrated a statistically significant and clinically meaningful enhancement in pulmonary nodule detection across all reader groups. Notably, in the multi-reader, multi-case study, the use of qXR-LN resulted in some emergency room physicians and pulmonologists approaching or surpassing the baseline (unaided)performance of radiologists.
“The need for early-stage lung cancer detection is crucial, and tools like qXR-LN can play a significant role in the early detection of incidental nodules”, said Dr. Vishisht Mehta, MBBS, FCCP, Director, Interventional Pulmonology, Comprehensive Cancer Centers of Nevada.
Qure.ai’s FDA-cleared solutions are introducing cutting-edge innovations across diverse applications. From quantitatively assessing the Cardiothoracic ratio for Cardiomegaly (Heart Failure) to aiding in the placement of endotracheal tube and tracheostomy tube and triaging critical pneumothorax and pleural effusion cases from chest X-rays. The portfolio extends further to triaging acute intracranial hemorrhage cases from non-contrast head CT scans, providing volumetric bleed measurement, cranial fracture detection, and maximal midline shift quantification.
