Digital Health – FDA
Dec 7, 2017 – The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies,; Improve …
Mobile Medical Applications – FDA
Jump to Does the FDA regulate mobile devices and mobile app stores? – FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers.FDA’s …
Press Announcements > FDA approves first telehealth option to …
Nov 17, 2017 – “Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to …
FDA regulates telemedicine on smart phones : CAMLAW …
As one law firm explains in Is Your Smart Phone An FDA-Regulated Medical Device? – FDA Announces Plans To Regulate “Mobile Medical Applications:”. The FDA views handheld computers loaded with these apps to be medical “devices” subject to extensive FDA regulation. The FDA’s draft guidance sets out its current …
FDA clears telehealth option to remotely program cochlear implants …
Nov 27, 2017 – FDA regulations · Telehealth · Mobile technology. print reprint. The Food and Drug Administration has approved the first telehealth option to remotely program electronic hearing devicescalled cochlear implants, rather than having audiologists make programming adjustments to them at specialized centers …
Thirty-six connected health apps and devices the FDA cleared in 2016 …
Dec 30, 2016 – While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software … Medtronic received FDA clearance for its AVIVO Mobile Patient Management System, which continuously measures, records and periodically transmits data for …
FDA Establishes New Digital Health Unit « Center for Telehealth and e …
May 12, 2017 – On the new unit’s agenda: topics like wireless medical devices, mobile apps,telemedicine, software as a medical device, and interoperability, among others. The overall focus will be on bringing “regulatory clarity” to the relatively new and continually evolving industry. In particular, theFDA is seeking to …
FDA OKs Telemedicine Platform for Programming Cochlear Implants
Nov 20, 2017 – The announcement continues a string of FDA approvals over the past month of innovative telemedicine and mHealth devices. This one is designed to help the 58,000 adults and 38,000 children who have received cochlear implants since 2012. The implant is designed to electrically stimulate the nerves …
Remote Patient Monitoring Technologies Addressed by FDA
Jul 31, 2015 – Among the many mobile apps and devices that the FDA does consider under the definition of a medical device but does not pose any serious danger to patients … Another remote patient monitoring solution that’s made an impact is Authentidate’s telemedicine service, which has helped monitor the health of …
Why Mobile Health Applications Require FDA Regulation
Aug 5, 2015 – August 05, 2015 – If a medical device like a pacemaker was to be installed through surgery and hadn’t been thoroughly vetted by the proper agency, what patient would ever allow their doctor to go through with the surgery? It’s likely no such patient exists and healthcare advocates expect all medical …