Qure.ai Secures 13th FDA Clearance for AI-Enabled Chest X-ray Solution to Detect Lung Nodules

qXR – LN is a computer-aided detection software designed to identify and highlight regions that indicate suspected pulmonary nodules ranging from 6 to 30 mm in size.

In a significant development, the US FDA has cleared HealthTech startup Qure.ai’s AI-enabled medical imaging solution- qXR-LN, the startup said this in a press statement.

This is the 13th FDA clearance for their AI-enabled medical imaging solutions and sixth for their chest X-ray-based solutions. qXR-LN, a chest X-ray-based solution is designed to identify and localize lung nodules using artificial intelligence.

The achievement marks a significant milestone for the company, which has been working on AI-powered advancements for plain film radiography and medical imaging.

qXR – LN is a computer-aided detection software designed to identify and highlight regions that indicate suspected pulmonary nodules ranging from 6 to 30 mm in size.

It can also serve as a crucial second reader for physicians and assist them in review of frontal chest radiographs developed on digital radiographic systems. The software termed as ‘Game-changer’ by the startup, is tailored for use in the adult population.

The development comes as an additional boost for the company, which has been looking to expand its footprint across North America.

Prashant Warrier, cofounder and CEO of 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.ai’s lung nodule solution is backed by two pivotal studies. The initial study showcased qXR-LN's standalone performance with an impressive 94% success rate for nodule detection. The second study, a multi-reader, multi-case clinical validation, demonstrated a significant enhancement in pulmonary nodule detection across various medical professionals. These included radiologists, pulmonologists, and emergency room physicians.

Dr. Mannudeep Kalra, a radiologist at Massachusetts General Hospital, foresees ongoing evolution in AI technology significantly advancing diagnosis and care, underscoring the vital role AI-driven solutions play in empowering radiologists.

Data suggests that lung cancer remains a leading cause of cancer-related deaths, and early detection can prove lifesaving. Statistically, 44% of cases in the US are not diagnosed until a late stage. Thus, AI-powered solutions like qXR-LN can play a critical role in early diagnosis.

Per Qure.ai, the software's ability to identify potential malignancies in pulmonary nodules offers a promising avenue for improving patient outcomes.

Dr Vishisht Mehta, director of Interventional Pulmonology at Comprehensive Cancer Centers of Nevada, noted that detection of incidental nodules is crucial in cases of Lung Cancer, and qXR-LN provides a significant tool for this purpose.

“Incorporating AI algorithms into diagnostic pathways has showcased their transformative impact on the field of medicine. Solutions like Qure.ai's qXR-LN are a significant step towards establishing new possibilities in pulmonary imaging, particularly within oncology,” he said.

Since its incorporation seven years ago, Qure.ai has emerged as a leading player in AI solutions for medical imaging globally. The startup secured an impressive tally of 22 patents in the last 18 months. Since its inception, it has amassed a remarkable 26 patents across various jurisdictions.

Qure.ai's FDA-cleared solutions extend beyond lung nodule detection, encompassing applications such as assessing Cardiothoracic ratio for Cardiomegaly, aiding in the placement of tubes, and triaging critical cases like Pneumothorax and Pleural Effusion from Chest X-rays. The portfolio also includes applications for intracranial hemorrhage cases from non-contrast head CT scans.