3ive Labs reposted this
Exciting Milestone Alert: Roivios is proud to announce our JuxtaFlow® Renal Assist Device (RAD) has been granted FDA Breakthrough Device Designation. This marks a pivotal moment in our mission to transform kidney health, particularly for patients undergoing cardiac surgery. This designation is a testament to the potential of JuxtaFlow® RAD to change the treatment paradigm for patients with kidney disease during cardiac procedures, leveraging a unique, gentle negative pressure technique. Our team will present compelling data at the Society of Cardiovascular Anesthesiologists, demonstrating the device's capability to protect against acute kidney injury (AKI). With plans to launch in the U.S. by late 2025, we're on track to revolutionize kidney health management. Stay tuned for more updates on our progress and impact. #Roivios #FDA #MedicalInnovation #KidneyHealth #CardiacSurgery #Protectthekidney