CardioRenal Systems, Inc.

About CardioRenal Systems

CardioRenal Systems, Inc. is a medical device company headquartered in Milford, Massachusetts (USA) with a location in Hamburg (Germany). The company developed the RenalGuard Therapy, a clinically validated procedure for the prevention of acute kidney injury (AKI) in cardiac surgery, in the intensive care unit, and in the catheterization lab. The therapy is based on guided matched-enhanced diuresis. The technology received the FDA Breakthrough Designation and is CE approved, with growing adoption in Europe and the Middle East. Clinical users include, among others, the Mediclinic Al-Ain Hospital and Fujairah Hospital in the UAE. The company is privately held and employs 11–50 staff.

Site

Milford, MA, USA

Processes

RenalGuard Therapy for the prevention of acute kidney injury (AKI) in cardiac surgery and the

Certificates

CE marking (CE approved), CE marking

Employees

11-50

Industries

Medical Devices, Cardiac Surgery, Interventional Cardiology, Intensive Care Medicine, Medical Devices / Medical Equipment Manufacturing

1. 01

   Research and Development

2. 02

   Regulatory Approval

3. 03

   Medical Device Manufacturing

4. 04

   Distribution and Clinical Training

5. 05

   Clinical Application

Locations

Inside the production

Quality and Approvals

The RenalGuard technology is CE approved and received the FDA Breakthrough Designation.

History

1. 2026

   FDA IDE approval for U.S. pivotal study; strategic investment from St. Elizabeth Healthcare and Angel Physicians Fund

2. 2026

   First implementation of the RenalGuard Therapy at the Mediclinic Al-Ain Hospital (UAE)

3. 2026

   Participation in EACTAIC 2026 in Maastricht (Booth 21)