FDA

By Jonah Comstock December 5, 2016
New York City-based Nanowear has received FDA clearance for SimpliECG, a "remote cardiac-monitoring undergarment". This is the first clearance for the company, which has been in talks with the FDA since 2015, according to a press release.  "This is a big milestone for our young company," Cofounder and CEO Venk Varadan said in a statement. "The FDA's decision not only positions us for commercial...
By Jonah Comstock December 1, 2016
Digital health hires news has been on the slow side around the holiday season, but there is at least one big piece of personnel news: Lisa Suennen, a digital health-focused investor, has joined GE Ventures as Managing Director, focused on healthcare.  Suennen invested with Psilos Group from 1998 to 2014 and for the last two years has been doing deals and consulting at her own firm, Venture...
By Heather Mack November 29, 2016
The 21st Century Cures Act – a long-debated bill that would allocate extra funding to the National Institutes of Health as well as effectively speed up the FDA approval process for drugs and devices – is headed for a House vote this week. The latest version of the bill, which was released over the holiday weekend, allocates $4.8 billion to the NIH over the next 10 years. The funding would go...
By Jonah Comstock November 28, 2016
Since its well-publicized meeting with the FDA in 2013, Apple has continued to meet with the agency regularly as well as to correspond by phone and email, according to emails obtained by MobiHealthNews via a Freedom of Information Act request to the FDA.   These emails show that Apple and the FDA have discussed the App Store review process, the 510(k) process, ResearchKit apps, diagnostic apps,...
By Heather Mack November 28, 2016
As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews has learned via a Freedom of Information Act request that the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device...
By Jonah Comstock November 28, 2016
Apple is working closely with the FDA to develop an FDA-regulated app for diagnosing Parkinson’s disease, MobiHealthNews has learned. The insight comes from a batch of emails MobiHealthNews obtained from a Freedom of Information Act request to the FDA. The tech giant held a meeting about Parkinson's at its headquarters in Cupertino in September 2015 attended by a number of neurologists and...
By Jonah Comstock November 28, 2016
Since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space, MobiHealthNews has learned. The revelation comes from a collection of emails MobiHealthNews obtained via a Freedom of Information Act request to the FDA.   On July 14, 2016, Robin Goldstein, at the time Principal Counsel for Apple, sent an email to FDA Associate Center...
By Jonah Comstock November 21, 2016
Ascensia Diabetes Care, a business unit created this year when Panasonic Healthcare Holdings acquired Bayer Diabetes Care, has received FDA clearance for a second connected glucometer device, the Contour Next One. Its previous device, the Contour Next Link, was cleared in August. While the Contour Next Link was designed specifically to connect to a Medtronic insulin pump, the Contour Next One is...
By Jonah Comstock November 14, 2016
It's been two years since the FDA passed its social media guidance for pharmaceutical advertising in limited-character formats -- that is, primarily, Twitter and Google sponsored links. Among other things, that guidance stipulated that, if a company wants to tweet about the benefit of a drug, they must include the "most serious risks" of that drug in the same tweet and that tweets must contain...
By Jonah Comstock November 11, 2016
The unexpected election of Donald Trump who, as a candidate, was weak on specific policy promises, has mired a lot of industries in uncertainty about their future, but perhaps none more so than healthcare. The Republican party has long sought to dismantle the Affordable Care Act, a landmark piece of legislation that has affected most parts of the healthcare landscape since it was passed in 2010...

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