FDA regulation

By MHN Staff 07:07 am March 3, 2014
By Bradley Merrill Thompson This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to have this discussion, and then I’ll get into the recommendations that the so-called “FDASIA working group” made with regard to how to improve FDA regulation. Current...
By Brian Dolan 07:19 am May 22, 2013
This week the US Food and Drug Administration sent a letter to Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urinanalysis system, that instructs the company to seek 510(k) clearance of its mobile medical app or convince the FDA that such a clearance is not necessary. Sending an "it has come to our attention letter" like this is a rare action for the...
By Brian Dolan 04:15 am March 28, 2013
Coinciding with the second day of congressional hearings on FDA regulation of mobile medical apps last week, McKesson announced the launch of a new app, Medisoft Mobile, for doctors and their staff that aims to make it easier to manage their practice through iPhones or iPads. Between the Medisoft Mobile app and the newest version of Medisoft software, care providers can now use their mobile...
By Neil Versel 02:20 am January 10, 2013
Verizon Communications is offering a top prize of $1 million for the most powerful healthcare innovation using the company's mobile, video and cloud technology. CEO Lowell McAdam announced the availability of the award Wednesday, as part of a $10 million challenge across three industries – also including education and sustainability – during his keynote address at International CES in Las Vegas...
By Brian Dolan 09:39 am June 15, 2010
If you have been following MobiHealthNews' series of contributed articles penned by Bradley Merrill Thompson, a strategic counsel at EBG Advisors, you know that the regulatory environment facing the mobile health industry is unfortunately about as murky as the Gulf Coast right now. In order to at least draw a line for those companies that believe they do not fall into an FDA regulated device...