Regulation

By Jonah Comstock 08:57 am June 4, 2015
FDA clearances for digital health devices are on track to triple by 2018, according to new research from Accenture, as digital health offerings drive more than $100 billion in savings over that same time period. Thirty-three digital health devices were cleared by the FDA in 2014, according to Accenture, and they predict 100 will be cleared in 2018. The research group estimates that FDA-cleared...
By Jonah Comstock 09:59 am June 2, 2015
New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer. The Bluetooth-connected device measures critical lung function with comparable accuracy to clinical-grade spirometers, and sends the data to a smartphone or tablet. Cohero Health has already been using the spirometer as part of its medication adherence tracking platform in a pilot at Mount...
By Brian Dolan 10:08 am June 1, 2015
As expected Australia-based medical device company dorsaVi has received a new FDA 510(k) that expands the use case for the suite of wearable sensors, called ViMove, to allow providers to use them for tracking additional static postures like a natural standing posture and various sitting postures. The new clearance also enables providers to use the devices to track healthy patients and establish a...
By Brian Dolan 08:24 am June 1, 2015
There's been a cluster of important telemedicine news in the past few days: the AMA is developing ethical guidelines for remote visits, a majority of states now have telemedicine parity laws in place, and details about Teladoc's business came to light through an SEC filing related to its hoped-for IPO. This month the American Medical Association's ethics council will begin to craft a set of...
By Jonah Comstock 11:03 am May 27, 2015
In the last two months, the FDA has cleared a number of clinically-focused mobile health devices. Some are first-time clearances for companies that have been waiting on their 510(k) for a while, including a few MobiHealthNews has been keeping an eye on over the years. Others are incremental clearances for slight hardware or algorithm updates. Here's five mobile health clearances that came through...
By Jonah Comstock 09:07 am May 7, 2015
The Senate Special Committee on Aging held a hearing yesterday to learn about the potential of aging in place technologies, including sensors and wearables. Aging In Place Technology Watch lead Laurie Orlov and VA Deputy Chief Patient Care Services Officer Maureen McCarthy testified, along with academics Marjorie Skubic from the University of Missouri and Carol Kim from the University of Maine....
By Jonah Comstock 10:26 am May 6, 2015
Dexcom was one of the first companies to announce that it would have an Apple Watch app, and a recent FDA guideline made it clear that, as a secondary display device for a cleared CGM, the Apple Watch app wouldn't require its own clearance. But users of other smartwatches, including the Pebble Watch and the Android devices have also had access to Dexcom CGM readings, just not through an...
By Brian Dolan 08:28 am May 4, 2015
This week the American Telemedicine Association's annual event is taking place in Los Angeles and apart from the important pair of policy-focused reports the ATA published (more on that below), the other news coming out of the event so far is that American Well has expanded its scope and is now working to convince physicians to use its platform to connect with their existing patients. While...
By Jonah Comstock 09:20 am April 30, 2015
An FDA-cleared clinical grade activity tracking system has come to the US for use in workplace injury prevention. The ViSafe system, from Australian company dorsaVi, has previously been deployed in Australia and the UK in fields ranging from retail to mining. "It’s our goal to reduce movement-related risk during the work task and we want to make workplace environments safer,"dorsaVi US president...
By Jonah Comstock 07:52 am April 30, 2015
One month ago, I wrote about how a Supreme Court case with little to do with digital health on the surface could turn out to be a game changer for telemedicine. It only took a month for the first lawsuit to put that new precedent to the test, and the players involved are big ones. Fresh off the news of its IPO filing, Dallas, Texas-based Teladoc sued the Texas Medical Board, alleging that a...