FDA medical devices

By Laura Lovett April 18, 2018
Digital health appears to be making its way onto the national stage. Yesterday, FDA Commissioner Scott Gottlieb gave the field a shout-out in his remarks to the US House Subcommittee on Agriculture, Rural Development concerning the Fiscal Year 2019 budget request for the FDA.  “The Budget requests new resources for the FDA to make significant investments in advancing critical areas of science,...
By Brian Dolan June 16, 2014
As MobiHealthNews noted last week in the introduction to our In-Depth report on Apple's Health app feature set, the FDA made a rare move on Wednesday by adding a new description for a type of mobile medical app that it would not regulate as a medical device. The FDA has actually added a total of four such new descriptions to its list in 2014. It just so happened that the latest app description to...
By Neil Versel December 13, 2011
CardioMEMS ran into a regulatory roadblock last week, when an FDA advisory panel recommended that the agency not approve the company's Champion HF Monitoring System. The device is said to be the first permanently implantable, wireless device for remote monitoring of patients with heart failure. Though the FDA's Circulatory Systems Devices Panel voted 9-1 that the implantable monitor was safe, the...