Tag: FDA
Second US clinical study for Alucent Biomedical’s AlucentNVS technology receives US...
At the beginning of November 2023, Alucent Biomedical announced via press release that it has received a US Food and Drug Administration (FDA) investigational...
First subjects enrolled in US clinical trial for VenoStent
VenoStent has announced that the first subjects have been enrolled in the SAVE-FistulaS clinical trial, which will take place at two different sites across...
Renal Interventions’ top 10 stories of November 2023
November was a month of demands for more vascular access (VA) training, novel technologies, and regulations, with Terry Litchfield highlighting the importance of compliance...
Shares drop for dialysis providers as Ozempic kidney failure study’s early...
In early October, Novo Nordisk announced they will stop the kidney outcomes trial FLOW at interim, after initial results and the recommendation from the...
FDA approves CorMedix Inc. DefenCath to reduce the incidence of catheter-related...
The US Food and Drug Administration (FDA) has approved CorMedix’s DefenCath, the first and only antimicrobial catheter lock solution (CLS) in the USA to...
Fresenius forced to recall haemodialysis machines due to potential toxic compound...
The Fresenius Medical Care 2008 Series haemodialysis machine recall has been issued with a class I label—the most serious type of recall—by the US...
Positive budesonide trial results earn FDA drug application approval
Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted a submission for a supplemental New Drug Application (sNDA) for...
Quanta receives US FDA 510(k) clearance for dialysis system
Quanta Dialysis Technologies has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta...
Remdesivir supplemental drug application for CKD patients approved by FDA
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the use of...
US FDA seeks to “modernise” clinical trials with new draft guidance
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design...
Digital dialysis device from liberDi receives FDA approval
liberDi announced today that it has received regulatory clearance from the US Food and Drug Administration (FDA) for its digital dialysis clinic, which allows...
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 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 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...
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 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...
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...