FDA Authorizes Athletic Collar To Reduce Brain Injuries
The Q-Collar is meant to work by improving blood flow to the brain, and has been shown to reduce signs of trauma from head impacts when playing sports.
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The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.
Digital Health Roundup, March 2021: Record-Breaking Funding; Exec Chats With Medtronic, Edwards LifeSciences
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news to date.