Medical Device Network

FDA clears Qure.ai’s lung nodule imaging suite

The FDA clearance allows for the newest edition to the company’s suite of lung imaging software designed to expedite diagnoses.

India-based AI firm Qure.ai has announced US Food and Drug Administration (FDA) clearance of its computed tomography (CT) imaging solution designed to help radiologists and pulmonologists examine lung nodules for signs of cancer.

The FDA has granted 510(k) clearance to the company’s AI-powered chest CT solution known as qCT LN Quant.

Qure.ai claims that qCT Quant can analyse individual lung nodules on non-contrast chest CT scans and track volumetric growth as part of progression monitoring in a bid to drive the early detection of cancer.

The AI system allows for the quantitative characterisation of solid lung nodules and enables clinicians to analyse morphological data across single or multiple thoracic studies. At the same time, it generates detailed 2D and 3D reconstructions of nodules and can provide decision-making suggestions for clinicians.

The software comes as part of an add-on to what the company calls the Qure.ai US AI-powered Lung Cancer care continuum, which has already seen use in several international health systems, including the UK’s National Health Service (NHS).

Bhargava Reddy, chief business officer of oncology at Qure.ai said: “This FDA clearance marks a significant milestone for Qure.ai’s mission to enhance lung cancer care in the United States. 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-optimised patient pathway, to evaluate lung nodules on at-risk patient CT scans, giving precise quantitative characterisation, plus tracking volumetric growth over time.”

The announcement follows shortly after the company was able to obtain Health Canada’s Class III medical device licence for its suite of AI solutions. Elsewhere in the AI-powered imaging market, competitor Avicenna.AI has secured Medical Device Regulation (MDR) certification for five of its AI algorithms used to screen for a host of conditions.