January 20, 2015
Bradley Merrill Thompson
At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an "accessory" device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall...
December 23, 2014
This year, MobiHealthNews covered many digital health milestones, including four IPOs, about $2 billion in funding, 33 merger and acquisition deals, and the entry of some big name companies in the space. But, this year also included some important moves by the FDA and, as always, a number of FDA clearances for digital health apps and devices.
In August, the FDA proposed to largely deregulate a...
June 10, 2014
When we first learned that a small team of Apple executives met with FDA officials last December to discuss mobile medical applications, it seemed likely that the discussion was intended to help Apple better avoid FDA regulation for its rumored health products. Thanks to a successful Freedom of Information Act request from the Apple-focused resources site Apple Toolkit, the FDA has furnished a...
May 9, 2014
By MobiHealthNews' count there are currently more than 35,000 unique, health-related apps available in various app stores. That includes everything from fitness and diet tracking apps to clinical decision support apps for doctors. Within that group we estimate that about 10,000 apps available today are intended for use by medical professionals.
For a few years now Apple has shared a variety of "...
April 10, 2014
This week the European Commission announced a consultation -- similar to a public notice from the FDA here in the US -- that asks digital health companies and others for help in identifying ways to encourage and regulate mobile health, which the Commission defines as "ways to enhance the health and wellbeing of Europeans with the use of mobile devices, such as mobile phones, tablets, patient...
March 19, 2014
Six US senators sent the FDA a letter this week to check in on the agency's interactions with mobile health app developers since it published its final guidelines for mobile medical app regulation last year. The senators who signed the letter -- Michael Bennet, Orrin Hatch, Tom Harkin, Lamar Alexander, Mark Warner, and Richard Burr -- stated that they wanted to ensure the agency's oversight over...
March 17, 2014
Durham, North Carolina-based Validic recently announced a $1.25 million convertible note from SJF Ventures and undisclosed angel investors. Validic CEO Ryan Beckland told MobiHealthNews that the new investment brings the company's total up to $2.1 million to date, but really serves as a bridge to get it to its series A round, which it is in the process of raising now.
Validic describes itself as...
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.
February 25, 2014
Telcare's Blood Glucose Monitoring System
Verizon recently received its second FDA clearance for its converged health management software platform, which MobiHealthNews first wrote about last August. While the intended use cases and overall technical aspects of the system haven't changed, Verizon has added support for Telcare's cellular-enabled blood glucose monitoring system and Genesis...
February 13, 2014
While the most recent meeting made headlines, the first time Apple executives actually met with the FDA wasn't at the end of 2013, but rather three-and-a-half years ago. The Financial Times pointed this out earlier this month.
On June 11, 2010 Apple's Vice President of Software Technology Bud Tribble and the company's VP of Worldwide Government Affairs Cathy Novelli met with the FDA's Director of...