FDA de novo

FDA looks to De Novo pathway model as it unveils updates to Pre-Cert program
By Laura Lovett | 11:25 am | January 08, 2019
FDA Comissioner Dr. Scott Gottlieb announced a new Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. 
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.
FDA approves Dexcom's CGM accessory app days after relevant draft guidance
By Jonah Comstock | 09:56 am | January 26, 2015