FDA

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...
By Jonah Comstock May 16, 2017
Swiss neurogaming company MindMaze has received FDA clearance for its MindMotion Pro platform, a motion capture system similar to the Microsoft Kinect which can be used in rehabilitation of stroke and traumatic injury patients. "In the last few years we’ve launched products at the intersection of the brain and VR," MindMaze CEO Tej Tadi told MobiHealthNews. "What we’ve done today very...
By Jonah Comstock May 11, 2017
Roy J.E.M. Raymann, who, as we reported yesterday, left Apple's sleep team a month ago, has moved to SleepScore Labs, a joint venture between ResMed, Dr. Oz Media, and Pegasus Capital Advisors. He will serve as Vice President of Sleep Science and Scientific Affairs. First announced this year at CES, SleepScore Labs is "currently in the process of examining how people sleep by compiling and...