DEERFIELD (dpa-AFX) - Baxter International Inc. (BAX) said Friday that it has received U.S. FDA 510(k) Clearance for its next-generation Artificial Kidney 98 dialysis machine. It is designed to be a portable and easy-to-use system to administer hemodialysis or HD treatments.
Artificial Kidney 98 or AK 98 offers encrypted, two-way connectivity, which enables the system to pull prescriptions directly from the electronic medical record (EMR) for simplified workflow and data handling.
According to the company, AK 98 is currently used in more than 90 countries globally and will be available in the U.S. in the coming week.
AK 98 offers several key features to help dialysis providers efficiently manage HD treatment sessions across chronic dialysis and hospital care environments. It includes Automatic Alert Resolution that 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.
AK 98 could be used alongside Theranova, Baxter's novel dialysis membrane.
The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25kg or more. The AK 98 dialysis machine is not intended for selfcare or home use, the company said in a statement.
Copyright RTT News/dpa-AFX
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