A Kentucky woman is suing Medtronic and the FDA alleging that the devicemaker’s spinal cord stimulator made her pain worse and that the agency didn’t diligently review updates to the implant. Angela ...

Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk ...

The bone graft incorporating rhBMP-2 has received FDA IDE approval for a pivotal clinical trial in spinal fusion ...

Orchestra BioMed Holdings shares rallied premarket after the maker of medical devices said a blood-pressure mechanism received breakthrough status from the U.S. Food and Drug Administration, allowing ...

Mursla Bio, a Cambridge UK and Boston US leader in Extracellular Vesicle (EV) science, has received FDA approval for its lead ...

Indianapolis-based software company Greenlight Guru, which helps medical-device makers more easily navigate the FDA approval process, said it has heard from numerous concerned customers.

Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary ...

The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

The US FDA has approved EBR System's leadless pacemaker WISE, the only heart device able to deliver left-ventricle ...

Sedana Medical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's application to initiate an Early Access Program for its investigational inhaled sed ...