Fresenius Medical Care’s 5008X Hemodialysis System Receives the US FDA’s 510(k) Clearance as a Dialysis Therapy for Kidney Disease Patients
Shots:
- The clearance was granted to 5008X Hemodialysis System, a high-volume hemodiafiltration dialysis therapy, based on the results from the (CONVINCE) multinational research study comparing 5008X Hemodialysis System vs conventionally used hemodialysis techniques for a duration of 3yrs. across 61 dialysis centers in 8 European countries
- The results from the study depicted that patients treated with high-volume hemodiafiltration experienced a 23% decrease in mortality rates vs those treated with conventional high-flux hemodialysis
- The clearance allows the company to initiate a clinical evaluation and user studies across the US with an expected commercial launch of 5008X Hemodialysis System by 2025
Ref: PR Newswire | Image: Fresenius Medical Care
Related News:- Fresenius Medical Care Recalls Few Models of Haemodialysis Machines for Potential Exposure to Toxic Substances in the US
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
