Roivios announced that it received FDA investigational device exemption (IDE) approval to conduct a trial for its renal assist device (RAD). The company can now move forward with a pivotal trial for the JuxtaFlow RAD for treating cardiac surgery patients with renal insufficiency. This IDE follows FDA breakthrough device designation for JuxtaFlow … [Read more...] about Roivios wins FDA IDE for renal assist device
Roivios
Roivios wins FDA breakthrough nod for renal assist device
Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD). The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys' … [Read more...] about Roivios wins FDA breakthrough nod for renal assist device
