The FDA has granted 510(k) clearance to clinical decision support software that uses AI to detect small but potentially cancerous lesions in the lungs.
U.K.-based Optellum says its Virtual Nodule Clinic is the first product to gain an FDA nod for applying AI to diagnose lung cancer early in its development.
The software computes a cancer-prediction score from patterns of 3D pixels on images acquired from standard CT scanners.
Optellum’s announcement quotes pulmonologist Anil Vachani, MD, of the University of Pennsylvania, who led a clinical trial featuring the software.
The lung cancer prediction score boosted sensitivity, specificity and consistency during the study, Vachani says.
Vachani adds that the product’s trial performance is significant because it suggests the software “could assist with early lung cancer diagnosis and intervention in today’s clinical practice, where many patients with cancerous nodules may face delays in diagnosis and treatment, while patients with benign nodules are often unnecessarily exposed to aggressive procedures with sometimes life-threatening complications.”
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.