Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and Radiological Health (CDRH) ...

To this end, we received notice last week from the FDA of Breakthrough Device Designation for the SCD in chronic dialysis. This is the fourth indication to receive this designation and the first for a ...

Plus, Donald Trump is set to visit the White House to meet with President Joe Biden for a symbolic meeting to signify a ...

Researchers at University of California San Francisco (UCSF) have developed a single genomic test that can quickly detect ...

In the United States, Revita is for investigational use only under US law. Revita has US FDA Breakthrough Device Designation ...

A decade-long effort has resulted in a new, rapid genomic test to diagnose rare infectious diseases in the brain and lungs.

The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019. CAUTION The fully implanted Acclaim Cochlear Implant is an ...

It seems like not a day goes by without billionaire Elon Musk making headlines. The boss of X (formerly Twitter), Tesla and SpaceX is the world's richest person and has used his platform to make ...