Mobile Medical Device – Interactive Tool

OMEDtechNews & Events, Uncategorized

There are more and more mobile health apps created every day.  Mobile medical devices and health apps must follow federal laws that apply to their product. The FTC has worked with the FDA, ONC, and OCR to release an interactive tool which will help mobile app developers understand which federal laws apply to their products. The user is able to … Read More

Apple Working with FDA on Mobile Medical Apps

OMEDtechNews & Events

Apple has been working on mobile medical apps.Executives from Apple and the FDA met in December to discuss mobile medical apps.  Some of the executives from Apple were: Jeff Williams (senior vice president of operations), Bud Tribble (vice president of software technology), and Michael O’Reilly (who has a background in medical devices as the former chief medical officer of Masimo Corporation).  … Read More

FDA Final Guidance on Mobile Medical Apps

OMEDtechNews & Events

Mobile Medical Applications The number of mobile applications and users are growing every day.  Included in this expanding technology is the category of mobile medical applications. “Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated … Read More