May 21 - 5:53
The US medical device regulating authority, the FDA, issued a Safety Communication on medical devices used for monitoring glucose levels. These devices are primarily used by patients with a high risk for diabetes. The...
May 16 - 6:10
The 21st Century Cures Act was groundbreaking and brought limitless possibilities to the field of medical treatment. Regenerative medicine advanced therapy, or RMAT, designations were created under this act to provide...
May 14 - 5:08
Implanted devices manufactured by 3-D printing are gaining more and more popularity nowadays. Canadian legislators are working to keep the existing regulations up to date and harmonized with the modern foreign...
May 7 - 5:39
The US regulating authority announced changes to existing regulations related to the reporting of medical devices. The information on upcoming changes was published in the recent report on breast implants and their...
Apr 25 - 5:18
The US Center for Devices and Radiological Health (CDHR), which is the branch of the FDA (the United States regulatory authority), issued a new Guidance on medical devices that generate images. The guidance includes...
Apr 18 - 4:23
The US Medical Device regulating authority, the Food and Drug Administration (FDA), has issued a Safety Communication to warn all potential users on risks associated with the use of unapproved diagnostic medical...
