FDA Reviews New Cancer Risk Tool for Early Detection in U.S. Patients
A new medical device, C the Signs, designed to identify early cancer risk in patients, is currently under review by the Food and Drug Administration (FDA). The tool, which analyzes patient medical records to detect cancer risk without additional tests, aims to refer patients at the earliest and most treatable stage of the disease. Already in use by over 11,000 healthcare professionals in the UK's National Health Service, it has detected cancer in 75,000 patients and reduced diagnostic timelines by 21%. The company behind C the Signs is pursuing a De Novo classification for the device, indicating it is a novel low-to-moderate-risk device with no existing predicate. The company plans to allow 250,000 Americans to use the tool this year as part of a study.