By Conor Hale, Fierce Biotech | September 26, 2019 A package of new guidance documents from the FDA describes what and how the agency plans to regulate as software designed to aid clinical decision-making—such as programs that provide documentation and diagnostic support or that call up medically relevant reference information and [...]
By Andrea Park, Becker's Hospital Review | September 26, 2019 The FDA released two new guidances on Sept. 26 further outlining its regulatory process concerning the development and commercialization of new digital health technologies. The first guidance concerns clinical decision support software. Besides distinguishing between types of software that will [...]
By Heather Landi, Fierce Healthcare | August 23, 2019 The Food and Drug Administration is in discussions with multiple stakeholders to create a universal unique medical device identifier to be stored in electronic health records and linked to patient outcomes to improve medical device surveillance, said FDA principal deputy commissioner [...]
MobiHealth News | July 19, 2019 The agency also warned consumers of unregulated diabetes products and outlined plans for AI device regulation. This quarter was another busy one for the FDA as it continued to reevaluate its approach to digital health amidst a changing of the guard from Dr. Scott Gottlieb [...]
By Eric Wicklund, mHealth Intelligence | July 17, 2019 The FDA is joining Yale University and the Mayo Clinic in a project aimed at studying the value of mHealth data gathered in a remote patient monitoring platform for people with heart failure. The US Food and Drug Administration is partnering [...]
By Andrea Park, Becker's Hospital Review | July 2, 2019 Here are five wearable devices that have received FDA clearance or approval for medical use in the first half of 2019: 1. The IB-Stim is a prescription-only, battery-powered electrical nerve stimulator worn behind the ear that emits low-frequency electrical pulses [...]
