Mobile Medical Devices
Year: 2014
Type: book-chapter
Abstract: In 2011, the Food and Drug Administration (FDA) released draft guidance on mobile device applications (Medical Device Data systems rule). A new type of medical device that integrates with smart phones and tablets is really pushing the traditional boundaries with the FDA. This area, compounded by the explosive growth of health-care-related mobile applications, has been forcing the organization to rethink and reinvent its review mechanisms. Mobile x-ray machines are one of the first types of devices that have taken advantage of the wireless network to transmit images to a central server. Electrocardiogram carts are often part of a larger system managed by the cardiology department. These can have a mobile form factor that can be rolled into a patient room and used for cardiac tests at the bedside. These are typically comprised of a mobile cart and several cardiac leads. Mobile ultrasound devices come in various shapes and sizes depending on their intended use.
Source: Auerbach Publications eBooks
DOI: 10.1201/b16580-6
Authors: Ali Youssef, Douglas McDonald II, Jon Linton, Bob Zemke, Aaron Earle
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W2482262747