Advances in technology will propel the cancer biomarker market to grow as more people use them to test, screen and determine risk for cancer.

Perhaps from shortly after the dawn of the 510(k) there has been the question of what changes to an existing 510(k) cleared Class II device require a new 510(k) submission. There is a companion question of how to document that a new 510(k) is not required when that decision is made.

Cancer patients across the country will soon be seeing Dr. Watson—so to speak. IBM Watson Health and Quest Diagnostics today debuted an offering that will use genomic tumor sequencing and machine learning to recommend personalized treatment options for patients.