Baxter gains FDA clearance for next-generation AK 98 dialysis machine

baxter international artificial kidney ak 98 dialysis machine
Baxter’s AK 98 dialysis machine

American healthcare firm and global renal care innovator Baxter International has announced US Food and Drug Administration (FDA) 510(k) clearance of its next-generation Artificial Kidney 98 (AK 98) dialysis machine, which is designed to be a portable and easy-to-use system for administering haemodialysis treatments.

According to a company press release, AK 98 offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from electronic medical records (EMRs) for simplified workflow and data handling.

“We designed this latest version of our AK 98 system to help dialysis providers minimise the operational challenges that can come with administering multiple haemodialysis sessions per machine, per day,” said Gavin Campbell, general manager of Baxter’s US Renal Care business. “With our recent De Novo authorisation of Theranova, our novel dialysis membrane, our latest innovations to support haemodialysis provide customers with choices for therapy and treatment modality.”

Due to kidney failure, people with end-stage renal disease (ESRD) retain harmful toxins in their blood. During haemodialysis therapy, blood is passed through a dialyser, which acts as the artificial kidney to filter toxins from the blood. The AK 98 dialysis machine offers several key features to help dialysis providers efficiently manage haemodialysis treatment sessions across chronic dialysis and hospital care environments, including:

  • Automatic Alert Resolution, which enables the machine to self-clear already-corrected pressure alarms and avoid unnecessary stoppage of treatment due to brief pressure fluctuations—often related to patient movement. This helps streamline patient management by limiting direct exposure and number of redundant device interventions.
  • An intuitive, customisable user interface with app-like functionality designed to simplify prescription management and treatment supervision.
  • A fast, simple setup process that can be completed by a technician or nurse, allowing for greater flexibility and utilisation of staff time, and resources.
  • A stable base design that allows for easy concentrate or portable reverse osmosis (RO) storage and transport with the machine.

According to Baxter, AK 98 is a proven dialysis platform that builds on the company’s “longstanding tradition of pioneering and delivering groundbreaking advancements in the haemodialysis space”. AK 98 is currently used in more than 90 countries globally and will be available in the USA in the coming weeks. Further information on the next-generation machine can be found here.


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