PHILADELPHIA — As the number of companies claiming to have created a device that assesses or diagnoses head injury increases, it is important to remember that the FDA has only granted 510(k) clearance to 14 such devices, a presenter at the American Academy of Neurology Annual Meeting said.
Consequently, Tanzid Shams, MD, a neurology specialist at Ballad Health in Tennessee, encouraged attendees to become active observers as more companies say they have developed these types of products.
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