We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
Clinical trial sponsor Brava was hit with an FDA warning letter over several informed consent violations and conflict-of-interest issues related to evaluations of its fat micro grafting device. Read More
The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products. Read More
Manufacturers of interventional cardiovascular devices may benefit from holding their first clinical trials in Europe, a clinical research organization advises. Read More