Qure.ai, a leader in AI-enabled medical solutions, has announced its 13th FDA clearance for their revolutionary AI-driven chest X-ray solution.

Qure's qXR-LN, designed to identify and localize lung nodules, has received clearance, marking the 6th FDA approval for the company's chest X-ray based solutions.

Qure's qXR for Lung Nodule (qXR – LN) represents a breakthrough in diagnostic technology, utilizing computer-aided detection software powered by Artificial Intelligence.

The solution is specifically tailored for use in the adult population, providing a crucial tool for the early detection of suspected pulmonary nodules ranging from 6 to 30 mm in size.

Prashant Warier, Co-Founder & CEO of Qure.ai, expressed the company's commitment to the US healthcare space, emphasizing the groundbreaking leap this FDA clearance represents. Having already implemented the solution globally, Warier highlighted the role of qXR-LN in combatting lung cancer and its potential as a second reader for physicians.

Two pivotal studies were conducted to establish the safety and efficacy of Qure's lung nodule device. In the initial study, qXR-LN demonstrated standalone performance meeting predefined success criteria, achieving an impressive Area Under the Curve (AUC) of 94% for nodule detection.

The study involved chest X-ray scans collected from 8 states and 40 individual sites across the United States, with performance assessed against the ground truth determined by American board-certified Radiologists.

The second pivotal study, a multi-reader, multi-case clinical validation, showcased the algorithm's enhancement in pulmonary nodule detection across various reader groups. Emergency room physicians and pulmonologists, with the aid of qXR-LN, approached or surpassed the baseline (unaided) performance of radiologists.

Lung nodule detection on plain film is critical for early malignancy risk identification, enabling timely interventions and improving patient outcomes. Accurate detection supports treatment planning, disease progression monitoring, and reduces false positives and negatives, contributing to cost-efficient and optimal healthcare.

Qure.ai's continued emphasis on innovation and commitment to advancing healthcare underscores its dedication to making a meaningful impact in the fight against lung cancer and improving patient outcomes.