Tag: US FDA

SNM system FDA Axonics

Axonics announces US FDA approval for its sacral neuromodulation system

Axonics, a medical technology company that has developed and is commercialising a novel implantable rechargeable sacral neuromodulation (SNM) device for the treatment of urinary and...

Latest FDA caution for the use of off-label drugs in intrathecal...

While the US Food and Drug Administration (FDA) has called for caution regarding the use of off-label medications administered intrathecally, pain management experts have...

Scott Gottlieb resigns as head of US FDA

The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...
shutdown

US government shutdown disrupting FDA work

The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...

FDA approval of Exablate Neuro for the treatment of tremor-dominant Parkinson’s...

InSightec has announced that The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has approved an expansion...

Stimwave receives FDA clearance for first Wireless SCS System with iPhone-iWatch...

Stimwave Technologies has announced that it has received US Food and Drug Administration (FDA) clearance for the WaveCrest Mobile iOS platform patient controllers for...

FDA recalls brain surgery device due to heating problem

The US FDA has alerted doctors to a problem with the Monteris Medical NeuroBlate probe in which the device may become unexpectedly heated during...

Robert Califf to resign as US FDA commissioner

Robert Califf is to step down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...