Optellum Virtual Nodule Clinic, including its proprietary artificial intelligence lung cancer prognosis solution, has achieved CE certification under the European Union Medical Devices Regulation.
Optelluman Oxford-based medtech company that provides cutting-edge AI technologies to aid in the early diagnosis of lung cancer, has achieved the CE mark for its Virtual Nodule Clinic – AI-driven clinical decision support software that helps clinicians identify and track at-risk patients. present suspicious lung nodules that may or may not have cancer.
This latest certification will allow use in the European Union (EU) and the United Kingdom (UK) and opens the door to European expansion for the growing company. This is the latest milestone for Optellum, which received FDA clearance of 510 (k) in early 2021, as the first application for AI – assisted diagnosis of lung cancer. Since then, the company has been supported by partnerships with the NHS with funding from Innovate UK and the National Institute for Health Research (NIHR) and has been implemented for patient use in some of the best US hospitals in the world, such as sample. Atrium Wake Forest Baptist, Vanderbilt University Medical Center (VUMC) and the University of Mississippi Medical Center (UMMC).
The Virtual Nodule Clinic integrates the clinically validated Lung Cancer Prediction (LCP) score based on AI imaging and has the potential to improve coordination and clinical care decisions, with the aim of treating patients before metastasis to the disease – which is crucial in increasing lung cancer survival rates. .
Lung cancer has the highest mortality rate of all cancers, with the current five-year survival rate at 20%. However, the survival rate for small tumors treated at Stage IA is as high as 90% – a difference that emphasizes the need for early diagnosis and treatment.1
The platform is currently being piloted by ten NHS hospitals as part of DOLCE – a landmark research project led by Professor David Baldwin, Honorary Professor of Medicine at the University of Nottingham, and Consultant Physician at Nottingham University Hospital NHS Trust . The project is part of the NHS AI Lab’s £ 140 million Health and Care AI Award to accelerate AI testing and evaluation in the NHS so that patients can benefit from faster and more personalized diagnosis and greater efficiency in screening services.
Professor Baldwin said: “There is strong evidence from carefully researched that the AI-based Lung Cancer Prediction tool does a better job of distinguishing between benign malignant nodules and the potential money savings on the NHS currently spent on repeat CT scans. The DOLCE study aims to confirm the results and quantify these savings and should be the final step in the full implementation of the NHS. ”
There is also Optellum is the leading industry partner in the UK DART (Data Using Artificial Intelligence to Improve Patient Outcomes for Thoracic Diseases) consortium, working with the NHS England Targeted Lung Health Check program which will provide lung cancer screening to approximately 600,000 eligible people.
Jason Pesterfield, CEO of Optellum, said: “CE marking will allow us to deploy our innovative AI in existing clinical settings in the UK, enabling physicians and patients to benefit from our technology without delay.
“It will also allow us to expand our commercial sales into Europe and build on our existing partnerships with some of the hospitals and clinics that were part of our early product development.”
Optellum was also recently featured in the AI Health Education England Roadmap Report2 reviewed the readiness of the NHS for the implementation of new AI technologies and the impact of these technologies on the workforce, the patient pathway and wider system performance.
Optellum achieves CE mark for its AI technology for early lung cancer diagnosis –
Source link Optellum achieves CE mark for its AI technology for early lung cancer diagnosis –