Dr. Scott Gottlieb

Scott Gottlieb
EVENT: Former FDA Commissioner Scott Gottlieb addresses bioelectronic innovation
By Anthony Vecchione | 11:48 am | October 24, 2025
At The Constellation Forum 2025 in New York, Gottlieb said there are and will continue to be challenges regulating software when it comes to AI devices.
Glooko's newest executives, Aetion's cross-industry data expert and more digital health hires
By Dave Muoio | 04:50 pm | February 17, 2020
Also: Jonathan Bush, Dr. Scott Gottlieb embrace the board of directors.
Gottlieb, whose FDA made major strides in digital health, resigns as commissioner
By Jonah Comstock | 05:45 pm | March 05, 2019
According to the Washington Post, which broke the news, the commissioner is leaving to spend more time with his family.
FDA's new draft guidance could hinder applications for digital combination products
By Dave Muoio | 05:18 pm | February 06, 2019
Released yesterday, the document outlines FDA's preference toward single applications for combination products.
FDA finalizes new 510(k) guidance, shifts away from aging predicate devices
By Laura Lovett | 03:17 pm | January 23, 2019
The new guidance aims to modernize the process and generate more market competition. 
FDA chief sees big things for AI in healthcare
By Mike Miliard | 10:13 am | April 30, 2018
2017 was an eventful year for digital health regulation at the FDA
By Dave Muoio | 04:42 pm | December 21, 2017
FDA opens applications for digital health pre-certification pilot program
By Jonah Comstock | 04:08 pm | July 27, 2017
New FDA commissioner lays out bold new plan for mobile app regulation
By Jonah Comstock | 04:55 pm | June 15, 2017
In past editorials, Trump's FDA pick advocated hands-off approach for health apps
By Jonah Comstock | 04:45 pm | March 13, 2017