New York/Mumbai, 08 January 2024: Qure.ai, a leading global innovator in medical imaging solutions, has announced its 13th FDA clearance for their AI-enabled solutions. Qure’s chest X-ray based qXR-LN uses artificial intelligence to identify and localize lung nodules, marking another significant milestone for the organization, strengthening its standing as a pioneer in the realm of AI-powered advancements for plain film radiography and medical imaging. This also marks the 6th FDA clearance for Qure’s chest X-ray based solutions. Notably, this is the only FDA-cleared solution for detecting and localizing lung nodules utilizing computer vision to have Radiologists, Pulmonologists and ER physicians as intended users. The introduction of AI solutions, such as qXR-LN, presents a remarkable opportunity to cast a wider net to identify potentially malignant pulmonary nodules, thereby boosting 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.

Prashant Warier, Co-Founder and CEO of Qure.ai, stated, “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. Our heightened emphasis on the North American marketplace solidifies our commitment to making a meaningful impact in the fight against this deadly disease and underscores our dedication to advancing healthcare through innovation, providing a transformative solution enhancing the early detection of cancer and ultimately improving patient outcomes.”
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.

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