FDA

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...
By Jonah Comstock June 7, 2017
At long last, Dexcom's Share app, which allows users to view and share data from their G5 continuous glucose monitors, will be available for Android users. The Android app just now received FDA clearance, and the company will roll out the app this month. The launch is a long time coming: iOS users have had access to the app since 2015. “Providing Android users with access to the Dexcom G5 Mobile...
By Jonah Comstock June 6, 2017
San Diego-based Clarify Medical has received FDA 510(k) clearance for its core technology, a handheld, smartphone-connected phototherapy device for treating various skin conditions.  “This is a major milestone,” CEO James M. Sweeney said in a statement. “We look forward to offering Clarify Home Light Therapy to patients throughout the country, beginning in November. It offers an in-office therapy...
By Jonah Comstock May 23, 2017
One year after the FDA declined to approve Proteus Digital Health and Otsuka's new sensor-embedded formulation of Otsuka's antipsychotic drug Abilify, the companies are giving it another shot, resubmitting the application with additional information. As before, the application is a New Drug Application (NDA) -- both the Proteus system itself and Abilify are already FDA cleared and approved,...
By Jonah Comstock May 23, 2017
What’s that on Tim’s wrist? Apple CEO Tim Cook has been wearing – and talking about – a prototype wristworn glucometer, according to a report in CNBC. Cook spoke to some students at the University of Glasgow about the device, but the company hasn’t shared any details. A rumor surfaced last month that Apple is working on a wrist sensor for blood glucose, which would be something of a gamechanger...

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