The Federal Food, Drug, and Cosmetic Act (FDCA) defines both drugs and devices as products “intended for use in the diagnosis of disease or other conditions,” in the “cure, mitigation, treatment, or ...

Caroline Woods: So Manoj, Cerezen is a medical device used to treat dementia and Alzheimer's. It just received certification for usage in the EU. We'll get to all of that. But first, for those who ...

Please provide your email address to receive an email when new articles are posted on . The FDA granted breakthrough device status to a novel system for the treatment of chronic limb-threatening ...

The FDA granted breakthrough device designation status to a coronary implant for patients with CAD. In a randomized controlled trial, the implant was linked to fewer adverse events at 2 years vs. DES.

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

ECG algorithm picks up Breakthrough Device status. Eko, the maker of tools for monitoring heart function, announced yesterday that a novel ECG-based algorithm for detecting lowered left ventricular ...