Fresenius (NYSE:FMS) said yesterday that it won FDA breakthrough device designation for its computer-assisted ultrafiltration control software intended to improve fluid management during hemodialysis.
The Waltham, Mass.-based company said that the software is designed to work with its newer hemodialysis machines using its CLiC device.
Fresenius said that with the software, it hopes to create a dialysis machine with embedded intelligent diagnostics to provide computer-assisted recommendations for achieving target levels of relative blood volume.
“This new software represents our commitment to driving innovation and aims to become an essential tool in reducing cardiovascular events for people living with kidney failure. Effective fluid management is critical to creating the best hemodialysis treatment possible for each individual. We are proud of this effort to further advance our proven Crit-Line technology,” renal therapies group prez Mark Costanzo said in a press release.
The company said that timelines for final development and approval of the computer-assisted ultrafiltration control software remains “uncertain given the nature of developing this complex and innovative technology.”
Earlier this week, Fresenius said that it’s planning a stock buyback of up to $370 million worth of its own shares.