de novo classification

Apple's ECG announcement was likely years in the making, but its timing was remarkable
By Jonah Comstock | 05:10 pm | September 13, 2018
The announcement has drawn questions about novelty and claims of coziness with the FDA.
How the FDA process is biased against new technology
By MHN Staff | 10:00 am | September 10, 2015
by Bradley Merrill Thompson Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea.