de novo classification

By Jonah Comstock September 13, 2018
Yesterday, Apple dropped a bombshell on the digital health world, as it is prone to do in its highly-produced launch events. While the announcement included fall detection on the Apple Watch and some improvements to heart rate monitoring, the headline was definitely the announcement that the Apple Watch Series 4 would contain an FDA-cleared ECG sensor. While much of the reaction has been positive...
By MHN Staff 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. Indeed, let’s say there’s nothing else like it. To bring the first tongue depressor to market, it’s quite likely I would have to spend years conducting clinical trials, to be followed up by perhaps a year of FDA review. For a tongue depressor. Why...