Recently, the FDA released a statement cautioning consumers against using unapproved apps and devices for diagnosing concussions. But, how are manufacturers getting away with illegally marketing devices and what can be done to stop them harming patients? Abi Millar finds out.
In April, the US Food and Drug Administration (FDA) released a warning to the public, advising them not to use unapproved medical devices or apps for diagnosing concussions.
These tools – which include smartphone apps marketed to sports coaches – could lead to an incorrect diagnosis, which in the case of head injuries is a serious problem. To date, only a few medical devices have been approved for diagnosing concussions, and none are targeted directly at the consumer. All require an evaluation from a healthcare 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,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, on a release. “Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law.”
The FDA said it would contact any companies that were flouting these rules, and would take action if its concerns weren’t addressed. Given the potential severity of head injuries, it’s easy to see why this warning was necessary.
Read the rest of this article in the July 2019 edition of Medical Technology