By Meg Bryant | June 21, 2018 Dive Brief: FDA’s device center released an updated version of its software precertification “working model,” known as Pre-Cert, laying out new details on the program's intended recipients and how it will differ from traditional premarket reviews. An original version was rolled out in April. [...]
By Eric Wicklund | May 31, 2018 Federal officials and healthcare organizations are ramping up efforts to use mHealth and telehealth to combat the nation’s opioid abuse epidemic. The U.S. Food and Drug Administration this week launched an effort to bring connected health technologies to bear on the issue. The [...]
By Stephanie Baum | MedCity News, April 26, 2018 The pharma industry’s use of digitized healthcare data and digital health tools to support drug development and quantify the impact on patient health has increased bit by bit over the past seven years. At the Health Datapalooza conference in Washington, D.C. this [...]
By Evan Sweeney | FierceHealthcare, April 18, 2018 To keep pace with emerging cyber threats, the Food and Drug Administration (FDA) is seeking congressional approval to develop a team of experts that could investigate cybersecurity incidents involving medical devices, while also adding new requirements for manufacturers. Medical device cybersecurity is one [...]
By MobiHealthNews | April 6, 2018 In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool. Not all [...]
By Stephanie Baum | March 28, 2018 The FDA pre-certification pilot program for digital health kicked off last year is due for expansion in the latter half of the year, according to a new report from RAPS. The program, run by the Center for Devices and Radiological Health, is part [...]
