December 30, 2016
Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration. While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software clearances, as the regulatory agency continues to evolve its position and expertise on how to regulate digital health tools. It’s been an...
July 21, 2016
We’ve compiled a list of our FDA-related coverage for first half of 2016. Eighteen companies received clearance for their devices, one was declined, and one group of patients published an editorial about their relationship with the FDA. Also this year, the FDA came out with some new guidance about how medical device makers should make data available to patients.
Read on for our roundup of...
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...
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...
April 13, 2015
By Bradley Merrill Thompson
With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor...
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.
January 16, 2014
Alere Connect, formerly known as MedApps before it was acquired by Alere, announced FDA clearance this week for its latest home health hub, HomeLink. The clearance rounds out Alere Connect's portfolio of hub devices to three main options: HomeLink, MobileLink, and HealthPAL. While each of the hub devices uses a cellular radio for backhaul -- no need to connect it via ethernet or your home WiFi...
January 7, 2014
iHealth's not yet FDA-cleared wearable ECG device
Mountain View, California-based iHealth Lab, a subsidiary of Chinese medical device company Andon Health, showed off three new smartphone-enabled, wearable health devices at CES in Las Vegas this week: a blood pressure monitoring vest, an ambulatory ECG device that sticks to the wearer's bare chest, and a wristworn pulse oximeter device.
July 22, 2013
This month the FDA cleared Westborough, MA−based Reflectance Medical's noninvasive, peel-and-stick sensor for measuring muscle oxygen saturation (SmO2) and pH (pHm), an indicator of tissue acidosis. Reflectance's Multi-Parameter Mobile CareGuide 3100, which simultaneously and continually measures those two parameters, secured Class II clearance. Quickly reversing acidosis can help prevent serious...
May 1, 2013
Proteus Biomedical's Raisin system
Redwood City, California-based Proteus Digital Health announced that it had raised $62.5 million in its latest round of funding led by Oracle with participation from existing investors Otsuka, Novartis, Sino Portfolio and others. MobiHealthNews reported on the first $17.5 million that Proteus raised for this round a year ago, so the $62.5 million includes an...