Companies worldwide are researching and creating tests to detect pancreatic and liver cancers at early stages to save lives and improve patient outcomes. In terms of regulatory approval, the US FDA categorizes medical devices under different classes based on risk. Class I (low risk) will require no FDA approval, Class II (moderate risk) will require FDA 510(k) clearance, and Class III (high risk) will require FDA approval. There is also the FDA breakthrough device program that speeds up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization for devices that provide more effective diagnosis of cancer than other devices currently on the market. A few tests that have received such FDA designations are Thermo Fisher's BRAHMS CgA II KRYPTOR test, that is the first and only FDA-cleared, fully automated chromogranin A assay used to detect gastroenteropancreatic neuroendocrine tumors 186 and also an AFP-L3% immunological test system that was cleared by the FDA in 2005 for the risk assessment of hepatocellular carcinoma. A few other tests have also received FDA breakthrough device designation such as GRAIL's Galleri test in 2019 188 and more recently in 2023, Burning Rock Dx's OverC test. A selection of companies that are researching early cancer detection for liver and/or pancreatic cancer are explored in Table to show the development and diversity within this emerging field.