Qure.ai Receives FDA Clearance for AI-Powered Lung Nodule Analysis Tool

What You Should Know:

– Qure.ai, a global innovator in medical imaging AI, has today announced a pivotal 510(k) FDA clearance for its AI-powered chest CT solution – qCT LN Quant.

– The new AI solution is now available to support radiologists and pulmonologists in analyzing lung nodules on non-contrast chest CT scans and tracking volumetric growth as part of progression monitoring.

Qure.ai Enhances Lung Cancer Care with AI-Powered qCT LN Quant

Qure.ai has integrated qCT LN Quant into its AI-powered lung cancer care continuum in the US, providing comprehensive solutions to identify, measure, manage, and monitor lung health. These tools support clinicians in healthcare institutions, driving early detection and improving patient outcomes.

Key components of Qure.ai’s lung health solutions include:

– qXR LN: Facilitates early detection and localization of lung nodules on chest X-rays, extending lung cancer detection capabilities beyond traditional CT-based screening methods.

– qTrack: A multi-modality lung nodule management platform that integrates seamlessly with Electronic Medical Records (EMRs), enabling clinicians to efficiently find, report, collaborate, and prioritize lung cancer patient cases.

qCT LN Quant offers advanced quantitative characterization of solid lung nodules, with features including:

– Measurement Capabilities:

  – Analysis of average, short-axis, long-axis, and effective diameters of lung nodules.

  – Evaluation of morphological data across single or multiple thoracic studies.

  – Estimation of volume doubling time and tracking nodules over multiple time points.

– Advanced Imaging and Decision Support:

  – Generation of detailed 2D and 3D reconstructions.

  – Calculation of Brock malignancy risk scores.

  – Provision of Fleischner Society guidelines-based management suggestions to ensure consistent and reliable clinical decision-making.

– Reimbursement Eligibility:

  – Potential eligibility under two CPT codes, including tissue quantification CPT 0722T for CT and 3D reconstruction code.

Qure.ai’s solutions are widely trusted globally, with real-world AI deployments at over 3,000 sites across more than 90 countries. The company has established partnerships, commercial deployments, and ongoing research studies with prominent institutions, including AstraZeneca, the UK’s National Health Service (NHS) hospitals, and leading teleradiology companies in the UK and US. Headquartered in Mumbai, Qure.ai operates regional offices in New York and London.