Oxford, England-based Optellum designed the Virtual Nodule Clinic as a clinical decision-support tool for helping clinicians identify and track at-risk patients who present suspicious lung nodules that may or may not be cancerous. The platform received FDA 510(k) clearance in March 2021.
Since receiving FDA clearance, Optellum has received support through partnerships with the National Health Service (NHS) with funding from Innovate UK and the National Institute for Health Research (NIHR), culminating in the European approval, according to a news release.
The Virtual Nodule Clinic integrates the clinically validated Lung Cancer Prediction (LCP) score based on imaging AI. Optellum said it has the potential to improve clinical care coordination and decisions with the intention of getting patients treated before the disease has metastasized.
Currently, the platform is being piloted at 10 NHS hospitals as part of the DOLCE research project, which is part of the NHS AI Lab’s $184 million (£140 million) AI in Health and Care Award to accelerate the testing and evaluation of AI in the NHS.
“Having CE marking will allow us to use our innovative AI in the existing UK clinical sites, enabling physicians and patients to benefit from our technology without delay,” Optellum CEO Jason Pesterfield said in the release. “It will also allow us to expand our commercial sales into Europe and further our existing partnerships with some of the hospitals and clinics that have been part of our early product development.”