Tag: guidewires
ElectroWire Medical receives US FDA 510(k) clearance for LightningWire transseptal puncture...
ElectroWire Medical has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its LightningWire transseptal puncture system, which is...
Atraverse announces first clinical use of Hotwire RF guidewire system
The Hotwire radiofrequency (RF) guidewire device from Atraverse Medical has been used for the first time in clinical practice by world-renowned cardiac electrophysiologist Devi Nair...
US FDA issues draft guidances for recommended premarket testing and labelling...
The US Food and Drug Administration (FDA) released the following two draft guidance documents: These guidance documents provide industry and FDA staff with recommendations on...