Tag: FDA clearance

Transit Scientific announces US FDA clearance for XO RX angioplasty platform

Transit Scientific has announced that the XO RX 2.2Fr and XO RX 3.8Fr platform has received US Food and Drug Administration (FDA) clearance to...

Alio remote monitoring technology receives first FDA 510(k) clearance

Alio has announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its remote monitoring system, which is intended for use...

CloudCath receives FDA clearance for novel at-home monitoring system in peritoneal...

CloudCath announced today it has received US Food and Drug Administration (FDA) clearance for the CloudCath system—which the company claims is the world's first...
baxter international artificial kidney ak 98 dialysis machine

Baxter gains FDA clearance for next-generation AK 98 dialysis machine

American healthcare firm and global renal care innovator Baxter International has announced US Food and Drug Administration (FDA) 510(k) clearance of its next-generation Artificial...
pristine catheter bd

BD gains FDA 510(k) clearance for Pristine long-term haemodialysis catheter

American medical technology company BD (Becton, Dickinson and Company) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Pristine...