FDA adds haemodialysis tubes to shortage list amid supply issues
The US Food and Drug Administration (FDA) has added haemodialysis bloodlines to its medical device shortages list amid supply disruptions.…
Nephrology and Urology Devices
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FemPulse wins FDA IDE to use overactive bladder vaginal ring in pivotal trial
FemPulse is set to enter the pivotal clinical trial phase with its neuromodulation system to treat overactive bladder after the…
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FDA labels Baxter’s haemodialysis machine recall Class I
Baxter has issued a correction for its AK 98 haemodialysis machines, with the US Food and Drug Administration (FDA) classifying…
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Sequana Medical’s DSR 2.0 outperforms traditional peritoneal dialysis solutions in study
Following positive data reported earlier this year from a Phase I/II trial, Sequana Medical has touted results from a study…
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EndoTheia completes trial of FlexStone device for kidney stone removal
EndoTheia has completed the clinical trial of its FlexStone Basket, an independently steerable device, designed for kidney stone removal. This…
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Xeltis wins FDA breakthrough status, enrols first patient in pivotal trial
Xeltis has hit two milestones for its vascular access conduit, with one coming in the regulatory arena and the other…
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FDA clears SonoMotion’s Stone Clear device to treat kidney stone fragments
SonoMotion has received the US Food and Drug Administration (FDA) de novo clearance for its Stone Clear device, a non-invasive…
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KFSHRC partners with University of Birmingham for bladder cancer diagnosis
King Faisal Specialist Hospital & Research Centre (KFSHRC) in Saudi Arabia has entered a five-year partnership with the University of…
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Astella’s iota receives FDA go-ahead for bladder implant trial
Astellas Pharma subsidiary, iota Biosciences, has won an investigational device exemption (IDE) from the US Food and Drug Administration (FDA)…
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Diality secures FDA 510(k) clearance for haemodialysis platform
Diality has announced the receipt of 510(k) clearance from the US Food & Drug Administration (FDA) for its Moda-flx haemodialysis…
