The JuxtaFlow RAD uses negative pressure technique to protect the kidneys from hypoxia-induced damage during acute conditions. Credit: Magic mine/Shutterstock.com.

Roivios has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its JuxtaFlow renal assist device (RAD), designed to provide kidney protection for patients undergoing cardiac surgeries.

This designation follows the positive outcomes of the BIPASS-AKI feasibility study and aligns with new research presented at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The FDA’s breakthrough device designation recognises the JuxtaFlow RAD’s potential to transform the current treatment landscape for patients at risk of kidney disease.

This device employs a new negative pressure technique to protect the kidneys from hypoxia-induced damage during acute conditions.

At the SCA Annual Meeting, Roivios will present preclinical data that demonstrates the JuxtaFlow RAD’s efficacy in reducing the adverse effects of cardiopulmonary bypass on kidney function.

This innovation has the potential to shorten ICU stays, decrease the necessity for emergency dialysis, and offer significant cost savings for healthcare systems.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

Roivios CEO John Erbey said: “Securing the breakthrough device designation marks a crucial milestone for Roivios and underscores our dedication to advancing kidney health innovation. We eagerly anticipate sharing the BIPASS-AKI clinical data soon. 

“We are proud to lead with innovative solutions like the JuxtaFlow RAD, which not only supports our unique approach but also our commitment to improving outcomes across a wide spectrum of conditions.”

With plans for the US launch in late 2025, Roivios aims to broaden the use of the JuxtaFlow RAD beyond cardiothoracic surgery to transform kidney health management across intensive care units.

In December 2023, the final participant was enrolled in the BIPASS-AKI study for the JuxtaFlow RAD at the Institute of Cardiovascular Diseases in Sremska Kamenica, Serbia.

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Awarded for Innovation in Remote Hearing Diagnostics , hearX’s Self Test Kit (STK) delivers clinically validated audiometry via smart devices, enabling remote, scalable hearing assessments in homes, clinics and retail. Learn how hearX is redefining hearing care delivery and reducing costs for providers globally.

Discover the Impact