SynCardia Systems, Inc. Regulatiory and Approvals

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SynCardia Systems, Inc. Regulatiory and Approvals

FDA, CE Mark and Health Canada Approvals of SynCardia Systems, Inc. Devices

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FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart
March 31, 2015 /3BL Media/ - SynCardia Systems, Inc. has received FDA approval to conduct an Investigational Device Exemption (IDE) clinical study on the effective use of its 50cc SynCardia temporary Total Artificial Heart. The FDA approval will allow SynCardia to launch the study with as many as 30 heart failure patients. Patients enrolled in this study will receive the 50cc SynCardia...
Mar 31, 2015 5:45 PM ET
FDA Approves the SynCardia Total Artificial Heart for Destination Therapy Study
January 7, 2015 /3BL Media/ - SynCardia Systems, Inc. has received FDA approval to conduct a clinical study of the effectiveness of the SynCardia temporary Total Artificial Heart for permanent use, also called destination therapy. On December 18, 2014, the United States Food and Drug Administration (FDA) approved the SynCardia Investigational Device Exemption (IDE) application to...
Jan 7, 2015 12:10 PM ET

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