Sharp Brains: Brain Fitness and Cognitive Health News

Neuroplasticity, Brain Fitness and Cognitive Health News

Icon

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:

The FDA Rec­om­mends Only Using Cleared or Approved Med­ical Devices to Help Assess or Diag­nose a Head Injury, Includ­ing Con­cus­sion

  • Pur­pose: The U.S. Food and Drug Admin­is­tra­tion (FDA) is con­cerned that prod­ucts that do not have FDA clear­ance or approval are being mar­ket­ed to indi­vid­u­als, includ­ing par­ents and care­givers, ath­let­ic coach­es, and health care providers for the assess­ment, diag­no­sis, or man­age­ment of a head injury, includ­ing con­cus­sion. The FDA is issu­ing this com­mu­ni­ca­tion to make the pub­lic and health care providers aware of the poten­tial seri­ous risks which may be asso­ci­at­ed with the use of unap­proved or uncleared med­ical devices for the diag­no­sis, treat­ment or man­age­ment of a con­cus­sion. The FDA reminds indi­vid­u­als to seek treat­ment by a health care provider if any head injury, includ­ing con­cus­sion, is sus­pect­ed.
  • Sum­ma­ry of Prob­lem and Scope: The FDA has iden­ti­fied sev­er­al man­u­fac­tur­ers that were mar­ket­ing med­ical devices for con­cus­sion diag­no­sis, treat­ment, or man­age­ment with­out the FDA’s approval or clear­ance. The use of unap­proved med­ical devices may lead to an incor­rect diag­no­sis. An incor­rect diag­no­sis of “no head injury” after an injury, for exam­ple, could lead a per­son with a seri­ous head injury to return to their nor­mal activ­i­ties instead of get­ting med­ical care. Not get­ting need­ed med­ical care and return­ing to nor­mal activ­i­ties could lead to wors­en­ing of the injury. To date, there are a lim­it­ed num­ber of med­ical devices that have been approved or cleared by the FDA to aid in diag­no­sis, treat­ment, or man­age­ment of head injury, includ­ing sus­pect­ed con­cus­sion and oth­er trau­mat­ic brain injuries. Addi­tion­al­ly, the FDA has not approved or cleared any devices that can assess or diag­nose a head injury, includ­ing sus­pect­ed con­cus­sion and oth­er trau­mat­ic brain injuries with­out an eval­u­a­tion by a health care provider.

News in Context:

Leave a Reply...

Loading Facebook Comments ...

Leave a Reply

Categories: Cognitive Neuroscience, Health & Wellness, Technology

Tags: , , , , ,

About SharpBrains

As seen in The New York Times, The Wall Street Journal, BBC News, CNN, Reuters,  SharpBrains is an independent market research firm tracking how brain science can improve our health and our lives.

Search in our archives

Follow us and Engage via…

twitter_logo_header
RSS Feed

Watch All Recordings Now (40+ Speakers, 12+ Hours)