510(k) Premarket Clearance Requirements for Medical Devices
When a manufacturer wishes to introduce a new medical device or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected, the manufacturer must provide the U.S. Food and Drug Administration (FDA) with a Premarket Notification (PMA) in the form of a 510(k) submission […]
Study Shows Concussions in Young Athletes Increasing Dramatically
The problem of concussions in athletes is an issue that has been receiving lots of press lately, in large part due to the new found understanding of the seriousness of these types of head injuries. In the past, concussions were believed to be mild injuries, requiring little if any follow up attention. However, as we’ve […]
Congress Considering Passage of Concussion Treatment and Care Tools Act
In a prior post, we discussed traumatic brain injuries and how concussions, once described as “mild” traumatic brain injuries, are anything but. More and more medical research is showing that concussions are serious injuries with lasting effects. The issue of the seriousness of concussions and the ramifications for athletes is becoming a hot topic. Both […]
Traumatic Brain Injuries: Are They Ever “Mild”?
Traumatic brain injuries have been in the news a lot lately, as more is learned about the long term effects of these injuries on professional athletes or anyone injured as a result of a blow to the head. As reported in this LA Times article, the NFL is now focusing on preventing brain injuries from […]