Tag: FDA

Outset Medical announces shipment hold on new Tablo haemodialysis systems for...

Outset Medical today announced it has implemented a shipment hold on the distribution of its Tablo haemodialysis system for home use pending the US...

X-Therma receives FDA Breakthrough Device designation for organ preservation and transport...

X-Therma has announced that the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted its proprietary...

FDA issues two final guidances for including patient perspectives in medical...

The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.   As...
alio

Alio and Lifeline create partnership for dialysis access patient monitoring

Alio has announced a partnership with Lifeline Vascular Care in support of patients living with end-stage renal disease (ESRD). Alio leverages artificial intelligence (AI)...

ImpediMed gains FDA Breakthrough Device designation for digital renal failure platform

ImpediMed, an Australia-based medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to improve patient health, has announced that the Sozo digital...
fist assist devices fa-1

Fist Assist device for focal arm massage and increased vein circulation...

Fist Assist Devices has received US Food and Drug Administration (FDA) 510(k) clearance for use of the Fist Assist FA-1 device in the USA...
new vascular access technologies

Nitric oxide, simulation and “living” grafts: Is the landscape of vascular...

The field of vascular access care for haemodialysis patients may look very different in just a few years’ time, with a host of new,...
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...