Optellum’s UK regulatory certification bolstered by UKCA marking for its early lung cancer diagnosis AI technology

After gaining CE certification for its software Virtual Nodule Clinic, Optellum has attained UKCA certification under the UK’s Medical Devices Regulations.

Optellum, an Oxford-based medtech company, provides breakthrough AI technologies to help with early diagnosis of lung cancer. One of its products, Virtual Nodule Clinic has now added UKCA to its growing list of regulatory clearances.

Following the UK’s departure from the European Union (EU), the UKCA mark is the new UK product marking that covers goods which previously needed EU CE marking. The new mark applies in England, Scotland and Wales (Great Britain), while CE marking will continue to be recognised in Northern Ireland. This latest certification will allow clinical use of the software in Great Britain to continue after June 2023, when CE marking ceases to be recognised for medical devices.

It is the latest milestone for Optellum, which received US FDA clearance in early 2021, as the first AI-assisted diagnosis application for 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 Optellum technology has been implemented in world-leading US hospitals.

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 tumours treated at Stage IA is up to 90% – a disparity which highlights a critical need for diagnosis and treatment at the earliest stage possible[1]. The Optellum Virtual Nodule Clinic integrates the clinically validated Lung Cancer Prediction (LCP) score, which is based on imaging AI, with the potential to improve clinical care coordination and decisions to get more patients treated before the disease has metastasised, aiming to increase lung cancer survival rates.

UKCA certification solidifies Optellum’s vital role in UK projects such as DOLCE, a landmark research effort led by Professor David Baldwin, Honorary Professor of Medicine at the University of Nottingham. DOLCE is part of the NHS AI Lab’s £140 million AI in Health Care Award, with Optellum’s AI technology being piloted at ten NHS hospitals.

Jason Pesterfield, CEO of Optellum, commented:

“Having the UKCA mark stabilises Optellum’s ongoing ability to provide our innovative AI technology to UK clinical sites.”

Optellum was also recently featured in Health Education England’s AI Roadmap Report[2] which reviewed the preparedness of the NHS for the implementation of new AI technologies and the impact these technologies will have on workforce, the patient pathway and wider system performance.

About Optellum

Optellum is a commercial-stage lung health company providing Artificial Intelligence decision support software that assists physicians in early diagnosis and optimal treatment for their patients. The company was founded so that every lung disease patient is diagnosed and treated at the earliest possible stage, when chances of cure are the highest. Optellum’s roadmap extends beyond lung cancer diagnosis and treatment to other deadly diseases of the lungs, including interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD). Optellum has headquarters at the Oxford Centre for Innovation in Oxford, United Kingdom and a US office at the Texas Medical Center in Houston, TX.

Optellum has received grant funding from InnovateUK, the National Institute for Health Research (NIHR), the NHS AI Lab, The Accelerated Access Collaborative (AAC), MedCity and EIT Health.

For more information, visit optellum.com, or follow us LinkedIn and Twitter.

[1] https://seer.cancer.gov/statfacts/html/lungb.html

[2] https://www.hee.nhs.uk/our-work/dart-ed/ai-roadmap