The Food and Drug Administration Aug. 17 issued a safety alert after reviewing the final results from a post-approval study conducted by SynCardia Systems for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System. SynCardia’s TAH-t functions as a bridge to a heart transplant in a small population of heart failure patients with severe bi-ventricular failure. The study results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver – the Circulatory Support System Console – FDA said. “We recommend that you carefully consider these mortality and stroke results from the TAH-t post-approval study when making treatment decisions, and discuss the risks and benefits of the C2 Driver System with patients,” FDA said in a letter to providers. FDA also encourages providers to report any adverse events or suspected adverse events experienced with the SynCardia TAH-t and Driver Systems.
The Department of Health and Human Services has updated its guidance to help communities prepare for and respond to chemical incidents requiring mass…
The Centers for Medicare & Medicaid Services has extended the deadline for submitting third-quarter data to the Post-Acute Care Quality Reporting Program.
The Food and Drug Administration Friday released draft guidance on how drug developers can apply for the agency’s Competitive Generic Therapies designation.
Hospitals and clinicians are seeing fewer flu patients this season than in other recent years, the Centers for Disease Control and Prevention reports.
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Members of the pharmaceutical distribution supply chain, including dispensers such as hospitals and pharmacies, can apply through March 11 to participate in a…