Unlike ischemic stroke, there is no consensus on the etiological classification of intracerebral hemorrhage (ICH). Our study focuses on two commonly used classification systems: SMASH-U and H-ATOMIC.

In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products. While the guidance is not binding, it provides industry ...

The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or ...