FDA

By Jonah Comstock January 17, 2017
Last November, as part of an investigative series on Apple's meetings with the FDA, we reported the company's stated plans to develop "two possible (and related) products in the cardiac space" which would require FDA clearance. In that report we speculated, based largely on a quote from Tim Cook in the Telegraph, that one of the products might be a wearable ECG built into an Apple Watch strap,...
By Heather Mack January 16, 2017
Health enterprise SaaS company Welltok announced an expanded partnership with IBM Watson Health. Health managers using Welltok’s CafeWell Health Optimization Platform to organize individual’s health resources and benefits will have the data analytics and cognitive computing technology of IBM Watson to improve their approach to consumer health, including episodic clinical care and everyday...
By Heather Mack January 11, 2017
IBM Watson Health has announced a joint initiative with the US Food and Drug Administration to study the use of blockchain technology to share health data to ultimately improve public health. At first, the two-year collaboration will focus on oncology data, pulling together and exchanging data from a variety of sources including that from clinical trials, genomic data, EMRs, and from...
By Heather Mack December 30, 2016
Over the past year, MobiHealthNews has covered 36 devices that received clearance from the Food and Drug Administration. While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software clearances, as the regulatory agency continues to evolve its position and expertise on how to regulate digital health tools. It’s been an...
By Jonah Comstock December 30, 2016
Over and above clearing a number of devices, the FDA had a busy year in 2016, passing a number of draft and final guidances related to digital health, having some notable conversations with vendors, and even turning down some devices whose FDA clearance was expected this year. We've rounded up the year's 510(k)'s in a separate article, but here's a rundown on some of the other actions the...
By Jonah Comstock December 20, 2016
The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.  "The FDA works hard...
By Jonah Comstock December 18, 2016
Updated with comments from Scanadu Scanadu, a personal health scanner company that shattered records on Indiegogo a few years ago, has raised $6.5 million according to an SEC filing. The new funding, a significant drop from the company's $35 million series B last year, comes at a time when the company is under fire for what many customers see as an unsatisfactory end to its FDA usability trial,...
By Heather Mack December 13, 2016
When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show how something truly operates in everyday life. But, according to a panel at the Connected Health conference in Washington, D.C, digital health tools that generate a trove of data could put us on...
By Heather Mack December 7, 2016
The 21st Century Cures Act has passed the Senate by a 94 to 5 vote, marking the last stop before President Obama’s desk to become a law. As we reported before, The Cures Act took three years to pass and was one of the most hotly-lobbied healthcare bills in the current Congress. It passed in the House last week. The bill allocates $4.8 billion to the National Institutes of Health over the next 10...
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...