Fresenius Kabi Submits 510(k) Notification for the Aurora Xi Plasmapheresis System Software Version 2.0 with New Nomogram [Yahoo! Finance]
Zimmer Biomet Holdings, Inc. (ZBH)
Last zimmer biomet holdings, inc. earnings: 2/4 06:00 am
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Source: Yahoo! Finance
Food and Drug Administration seeking clearance of the Aurora Xi Plasmapheresis System software version 2.0. The Aurora Xi Plasmapheresis System is currently cleared in the United States for source plasma collection using two existing nomogram algorithms (Standard and Optimized), which determine the amount of plasma to be collected from donors. Aurora Xi Software Version 2.0 includes a new, adaptive nomogram that uses each donor's unique characteristics to target a collection volume. "We are excited for the potential of the Aurora Xi Software Version 2.0 to provide U.S. source plasma collectors with a new and proprietary nomogram option. This new nomogram was developed to target a unique volume of plasma for each donor," said Dr. Christian Hauer, President MedTech at Fresenius Kabi. "Fresenius Kabi is committed to investing in innovation for the source plasma industry which is critical to assure that people who depend on plasma-derived therapies have access to them." The 510(k) s
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ZBH
Earnings
- 10/30/24 - Miss
ZBH
Sec Filings
- 11/20/24 - Form 8-A12B
- 11/20/24 - Form 8-K
- 11/19/24 - Form 8-K
- ZBH's page on the SEC website