Day: June 18, 2020

In a first of its kind, this week FDA approved a video game as a medical device for the treatment of children with ADHD. Besides the happy children who have one more reason to play more video games (as if they needed one), this presents a new opportunity for game developers. With this decision, FDA … Read more

More than 1300 Chinese companies used one fictitious address and US Agent information to register with the FDA and exported products to the US that did not meet US requirements, and it may be the tip of an iceberg. Preliminary searches on FDA’s database for registered device manufacturers include 13,751 Chinese device companies, which represent … Read more