If mishandled, this move could undermine public trust in the FDA and squander a once-in-a-generation opportunity to lead the ...

The EnVisio X1 platform is currently under development stage and unavailable for sale or clinical usage in the US.

The Final Rule was mooted for implementation over a staged transition period, determined by a service’s risk level, by 2028.

If you or someone you love is concerned about Alzheimer’s disease, the process of detecting its presence can involve a series ...

The FDA has granted approval to Teal Health’s at-home vaginal sample self-collection device, Teal Wand, for cervical cancer ...

The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety ...

Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements ...

The FDA has approved the first blood test for diagnosing Alzheimer’s disease, which could speed the path to treatment for ...

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...

The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker ...