Qure.ai Secures FDA Clearance for its AI-powered Chest CT Solution

This tool allows clinicians to measure various dimensions of solid lung nodules, including average, short-axis, long-axis, and effective diameters.

Qure.ai, an innovator in medical imaging AI, has received 510(k) FDA clearance for its AI-powered chest CT solution, qCT LN Quant.

This advanced tool aims to assist radiologists and pulmonologists in quantifying and monitoring lung nodules, potentially enhancing lung cancer care.

The newly cleared qCT LN Quant is designed to analyze lung nodules on non-contrast chest CT scans, tracking their volumetric growth over time. This tool allows clinicians to measure various dimensions of solid lung nodules, including average, short-axis, long-axis, and effective diameters.

Moreover, qCT LN Quant can estimate the volume doubling time of nodules, track their progression across multiple studies, and provide detailed 2D and 3D reconstructions.

The solution also integrates Brock's malignancy risk scores and Fleischner Society guidelines, offering consistent clinical decision support.

The QCT LN Quant could be reimbursable under two CPT codes: tissue quantification CPT 0722T for CT and the 3D reconstruction code.

Enhancing Lung Cancer Care

Qure.ai's qCT LN Quant is a part of the company’s broader US AI-powered lung cancer care continuum.

This continuum includes end-to-end AI solutions such as ‘qXR LN’ for early lung nodule detection on chest X-rays and ‘qTrack,’ a lung nodule management platform that integrates with Electronic Medical Records (EMRs). These solutions aim to support early lung cancer detection and facilitate lung health management in clinical settings.

"This FDA clearance is a significant milestone for Qure.ai’s mission to enhance lung cancer care in the United States. With qCT LN Quant, we have an advanced solution to evaluate lung nodules on at-risk patient CT scans, providing precise quantitative characterization and tracking volumetric growth over time," stated Bhargava Reddy, Chief Business Officer, Oncology at Qure.ai.

Qure.ai has a robust presence in the global healthcare landscape, with AI deployments in over 3,000 sites across over 90 countries. Major institutions trust the company and have ongoing partnerships, commercial deployments, and research studies with prominent organizations, including AstraZeneca, the UK’s National Health Service (NHS) hospitals, and leading teleradiology companies in the UK and US.

Dr Javier Zulueta, Chief of Pulmonary, Critical Care and Sleep Medicine at Mount Sinai Morningside, New York, commented on the significance of this advancement, saying, "It is encouraging to see the continuous FDA clearances that allow the exploration and activation of algorithms to support radiologists and pulmonologists. These tools help detect lung nodules earlier using chest X-rays and analyze them in detail on chest CTs."