Baxter receives FDA clearance for ‘artificial kidney’ dialysis machine
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The FDA has granted 510(k) clearance to Baxter for its portable hemodialysis machine, titled Artificial Kidney 98. The machine is already used in 90 countries, according to a press release.
The release noted some key features of the machine, which include its ability to obtain data from electronic medical records, a “customizable user interface with app-like functionality designed to simplify prescription management” and a set-up design that can be performed by nurses or technicians.
“We designed this latest version of our [Artificial Kidney] AK 98 system to help dialysis providers minimize the operational challenges that can come with administering multiple hemodialysis sessions per machine per day,” Gavin Campbell, general manager of Baxter’s U.S. Renal Care business, said in the release. “With our recent de novo authorization of Theranova, our novel dialysis membrane, our latest innovations to support [hemodialysis] HD provide our customers with choices for therapy and treatment modality.”
Baxter expects the machine to be available in the United States in the “coming weeks,” according to the release, and is currently cleared for use in the chronic care dialysis or hospital care environment. It is not intended for self-care or use at home.
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