Kinsa's smartphone-connected thermometer
The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their...
Vital Connect's HealthPatch
This past month the FDA cleared two mobile medical apps and one digital health platform as 510(k) Class II medical devices.
McKesson, one of the most vocal health IT companies lobbying for changes to how the FDA regulates medical software, secured clearance for a mobile medical app called McKesson Cardiology ECG Mobile. The web-based version of McKesson Cardiology...
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...
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...
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...
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...
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...
