FDA regulated mobile medical apps

By MHN Staff October 15, 2015
By the MobiHealthNews team This morning a number of big name medical institutions launched new studies using Apple's ResearchKit, iPhones and, in at least one case, the Apple Watch. As more ResearchKit study apps become available on Apple's app store, it appears that many of them are laying the groundwork for future FDA-cleared medical apps. It not only seems to be the case, the medical...
By Brian Dolan February 9, 2015
FDA's Bakul Patel Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status. Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where...
By Brian Dolan November 26, 2013
There are now more than 100 mobile medical apps registered with or cleared by the FDA as medical devices, according to MobiHealthNews' just-updated report, aptly named: The 103 FDA Regulated Mobile Medical Apps. When we first published our extensive round-up of FDA regulated mobile medical apps in December 2012, we found 75 apps in FDA's databases. This time around we added those that received...