US-based health technology company Qure.ai has secured the US Food and Drug Administration (FDA) 510(k) approval for its AI-powered chest CT solution, qCT LN Quant.
The new qCT LN Quant offers an advanced quantitative characterisation of solid lung nodules, measuring average, short-axis, long-axis, and effective diameters.
It allows clinicians to analyse data across single or multiple thoracic studies, including estimated volume doubling time and tracking of nodules over several time points.
Also, it generates detailed 2D and 3D reconstructions, Brock malignancy risk scores, and Fleischner Society guidelines-based suggestions to support clinical decision-making.
qCT LN Quant supports radiologists and pulmonologists in analysing lung nodules on non-contrast chest CT scans, tracking volumetric growth, and driving early detection, said Qure.ai.
Qure.ai oncology chief business officer Bhargava Reddy said: “This FDA clearance marks a significant milestone for Qure.ai’s mission to enhance lung cancer care in the US.
“Already, we’re starting to see the power of AI for incidental pulmonary nodule detection using chest X-ray, across multiple care settings, to boost lung surveillance, especially in states with low lung cancer screening CT uptakes.
“Now, we have the next stage solution in the AI-optimized patient pathway, to evaluate lung nodules on at-risk patient CT scans, giving precise quantitative characterisation, plus tracking volumetric growth over time.”
Qure.ai said its new solution, a part of its AI-powered Lung Cancer care continuum in the US, includes advanced AI solutions to identify, measure, manage, and monitor lung health.
The health tech company offers qXR LN for the early detection and localisation of lung nodules on chest X-rays to support early lung cancer detection beyond traditional CT-based screening.
Its qTrack multi-modality lung nodule management platform integrates with Electronic Medical Records (EMRs) to help find, report, collaborate, and prioritise lung cancer patient cases.
Furthermore, Qure.ai expects its qCT LN Quant solution to be eligible under two CPT codes for reimbursement, tissue quantification CPT 0722T for CT and 3D reconstruction code.
Mount Sinai Morningside division of pulmonary, critical care and sleep medicine chief Javier Zulueta said: “Medical imaging AI holds immense potential in the battle against lung cancer in the US. “It is great to see the breadth of FDA clearances rolling in to enable the exploration and activation of algorithms that can support radiologists and pulmonologists. This will help to detect lung nodules earlier using chest X-ray and also analyse them in detail on chest CT.”
