FDA

By Jeff Lagasse August 16, 2017
Diabetes therapy management software company Glytec has just secured its fourth FDA clearance, adding a slew of capabilities to its Glucommander product, the core of its eGlycemic Management System.   This latest FDA clearance incorporates some of the product enhancements that have been suggested by the company’s user community, including a titration module designed expressly for inpatients...
By Jonah Comstock August 11, 2017
As implantable CGM company Senseonics continues to wait for clearance from the FDA, the company isn't sitting on its hands. On a Q2 earnings call, CEO Tim Goodnow reported that the company continues to expand its operations in Europe, is close to a CE Mark for a longer-lasting second generation device, and is partnering with Roche and Type Zero on an artificial pancreas study with an eye on...
By Jonah Comstock July 31, 2017
Over the last month, several digital health companies have wound their way through the FDA clearance process. Although the details on some of these clearances are still emerging, the following is a snapshot of some of what the agency has been up to. Dictum Health's telemedicine platform Dictum Health, which makes an end-to-end telehealth platform, receieved clearance to add spirometry to the...
By Jonah Comstock July 27, 2017
The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr. Scott Gottlieb last month. Now the agency has opened up applications for a nine-company pilot program to develop the program. The basic goal of the Pre-Cert program, which sets it apart from previous...
By Jonah Comstock July 26, 2017
HIMSS has named Harold “Hal” Wolf III to be its new president and chief executive officer, following an extensive search process, the association announced Wednesday. He will succeed H. Stephen Lieber, who is stepping down as HIMSS CEO after more than 17 years. Wolf has more than three decades of experience working in healthcare and technology, with deep expertise in integrated care models,...
By Jeff Lagasse July 21, 2017
The FDA has been a busy agency these past few months. The second quarter of 2017 has seen a flurry of clearances, many for technologies that continue the trend toward mobile, or even wearable devices. It’s been a good period for those with diabetes, sleep disorders and traumatic injury, not to mention those just looking to maintain and manage their health – with a little digital help, of course....
By Jeff Lagasse July 20, 2017
Global digital health outfit DarioHealth Corp., which emphasises mobile health and data solutions, has been granted Pre-market Notification (510(k)) clearance for the Dario app on certain Android mobile devices by the U.S. Food and Drug Administration. Dario is a glucose meter that syncs with a companion app. The device, which is small enough to fit in someone’s pocket, consists of a glucose...
By Jeff Lagasse July 19, 2017
Note: This article has been updated to clarify the claims being made by Milestone Scientific about its new technology. If Milestone Scientific has its way, epidural procedures will no longer be done blindly by feel.   The company has developed a technology that will be used for epidural procedures, and allows anesthesiologists and other clinicians the ability to determine the pressure at the tip...
By Jonah Comstock June 15, 2017
Back in March, when President Donald Trump chose Dr. Scott Gottlieb to head up the FDA under his administration, MobiHealthNews noted that he had a history of advocating for a hands-off approach to mobile health regulation. Now, just three months later (and a little over a month after his confirmation to the post), Gottlieb has articulated his new -- and somewhat radical -- approach to mobile...
By Jonah Comstock June 8, 2017
iRhythm Zio is in many ways a poster child for a connected health company. The company, which makes a peel-and-stick patch for mobile ECG recording, is one of the few wearable medical device companies to go public, and few digital technologies have as soundly improved on the status quo as Zio has on the Holter monitor, a long-term legacy monitoring technology. There's only one problem with...