medical device regulation

Medical device manufacturers face challenges preparing for ‘stringent’ new EU Regulation
By Tammy Lovell | 06:15 am | February 12, 2020
Trade association raises concern that new regulatory system is not ready to support the transition of technology.
Fragmentation, regulations pose unique challenges for Europe's digital health market
By Laura Lovett | 01:51 pm | December 06, 2019
This week at the EIT Health Summit in Paris entrepreneurs, industry players, regulators and investors came together to discuss the opportunities for health innovation in Europe, and its relationship to the US market. 
How the FDA process is biased against new technology
By MHN Staff | 10:00 am | September 10, 2015
FDA clarifies the line between wellness and regulated medical devices
By Brian Dolan | 06:39 am | January 16, 2015
FDA tells 23andMe to stop, get clearance
By Jonah Comstock | 07:19 am | November 25, 2013
Concern: Security of wireless implanted devices
By Brian Dolan | 05:14 am | July 05, 2010
Will the FDA regulate mHealth care providers?
By Brian Dolan | 12:13 pm | April 19, 2010