Roivios Receives FDA Breakthrough Device Designation for JuxtaFlow® Renal Assist Device

Roivios has received the prestigious Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its innovative JuxtaFlow® Renal Assist Device (RAD), which represents a significant step forward in preserving kidney function in patients undergoing cardiac surgery and addresses a key challenge in cardiothoracic surgery and critical care.

The Breakthrough Device Designation highlights the JuxtaFlow® RAD’s potential to fundamentally change the treatment paradigm for patients with renal disease during cardiac surgery. The device uses a unique, gentle negative pressure technique on the kidney’s urinary collecting system to improve function and protect against hypoxia-induced damage in acute conditions. This breakthrough has the potential to reduce the length of stay in intensive care units, minimize the need for emergency dialysis and generate significant savings for healthcare providers.

With the expected launch of the JuxtaFlow® RAD in the US in late 2025, Roivios will expand the use of the device beyond cardiothoracic surgery to revolutionize renal health management throughout the ICU.

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