FDA

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...
By Jonah Comstock May 18, 2017
As Scott Gottlieb kicks off his tenure as FDA commissioner, former commissioner Robert Califf has a new gig as well. Califf revealed in a blog post that he has taken a job at Verily, the life sciences arm of Alphabet, as well as returning to professorial positions at Duke and Stanford. Although the details of his role are still unclear, Califf will work on Verily’s Baseline study, an effort to...
By Jonah Comstock May 16, 2017
Ashkelon, Israel-based Oxitone Medical has received FDA clearance for a wristworn pulse oximeter that doesn't require a finger clip. According to the company, the device – the Oxitone 1000 – can pick up SpO2 and pulse rate with the same accuracy as traditional fingertip pulse oximeters. The device has a consumer-friendly form factor, but Oxitone is targeting the clinical market. The design of the...