By Laura Lovett, Healthcare IT News | September 14, 2018 Though not without critics, the FDA has advanced regulatory processes for apps, medical devices, genomics and clinical decision support. The U.S Food and Drug Administration serves a critical role in healthcare innovation by regulating a range of medical devices and [...]
By Kevin Truong, MedCity News | September 13, 2018 Apple Watch's entry into the device world garnered a ton of attention and praise, but a good portion of observers have reservations about whether it will truly move the needle in healthcare. Apple’s big news that it received FDA clearance for [...]
By Conor Hale, FierceBiotech | July 30, 2018 The FDA recently finalized an eagerly awaited guidance on the incorporation of electronic health records and real-world data into clinical trials and product submissions, including the use of patient medical histories, pharmacy records, radiology scans and lab test results from routine care, [...]
By Scott Gottlieb, M.D, FDA Voice | July 10, 2018 Over time, as our experience with new medical products expands, our knowledge about how best to maximize their benefits and minimize any potential risks, sharpens with each data point we gather. Every clinical use of a product produces data that [...]
By MobiHealthNews | July 5, 2018 Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request. In fact, the FDA is turning to developers in the digital health space to help solve some [...]
By Eric Wicklund | June 22, 2018 Federal officials have given the green light to an implantable mHealth device designed to help people with diabetes and their caregivers remotely monitor blood glucose levels. The U.S. Food and Drug Administration’s approval of the Eversense CGM (continuous glucose management) system, developed by [...]
