The FDA warns consumers not to use unapproved apps and devices to diagnose concussion

_______ FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion (news release): Today, the U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. In a new safety communication, the FDA warned that such tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting medical care. To date, there are a limited number of medical devices that have been cleared or approved by the FDA to aid in the diagnosis, treatment, or management of concussion, and all of them require an evaluation by a health care professional. “I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. The FDA Safety Communication: Th...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Cognitive Neuroscience Health & Wellness Technology concussion FDA head-injury medical devices TBI Traumatic-Brain-Injury Source Type: blogs