The United States Food and Drug Administration (USFDA) has approved Qure.ai’s Artificial Intelligence (AI)-enabled solution for chest X-ray. The solution based on qXR-LN uses AI to identify and localise lung nodules. The approval marks the sixth FDA clearance for the company’s solution in this regard, a statement from the company notified.
According to the statement, this is the only FDA-cleared solution for detecting and localising lung nodules utilising computer vision to have radiologists, pulmonologists and Emergency (ER) physicians as intended users. The introduction of AI solutions, such as qXR-LN, presents an opportunity to cast a wider net to identify potentially malignant pulmonary nodules, thereby boosting the fight against lung cancer.
The statement also noted that qXR for Lung Nodule (qXR – LN) is a computer-aided detection software designed to identify and highlight regions indicative of suspected pulmonary nodules ranging from 6 to 30 mm in size.
Prashant Warier, Co-Founder and CEO, Qure.ai, stated in the statement, “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 make a meaningful impact in the fight against this deadly disease and underscores our dedication to advance healthcare through innovation, providing a transformative solution enhancing the early detection of cancer and ultimately improving patient outcomes.”
Qure.ai conducted two pivotal studies to establish the safety and efficacy of its lung nodule device. In the initial pivotal study, the company demonstrated standalone performance that met predefined success criteria, achieving an Area Under the Curve (AUC) of 94 per cent for nodule detection. The study involved qXR-LN and included chest X-ray scans collected from eight states and 40 individual sites across the US. The device’s performance was assessed against the ground truth determined by five American board-certified radiologists. They interpreted chest X-rays alongside corresponding CT scans and reports, with the ground truth based on nodules visible on the Chest X-ray, added the statement.
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, it further mentioned.
Lung nodule detection on plain film is crucial for the early identification of malignancy risk, enabling timely interventions and improving patient outcomes. Accurate detection aids in treatment planning, disease progression monitoring and the reduction of false positives and negatives, contributing to cost-efficient and optimal healthcare, the statement added.