Heater-Cooler Systems Face FDA Scrutiny
This article was originally published in The Gray Sheet
Executive Summary
The agency has issued a safety alert on the risk of bacterial infections linked to the use of LivaNova/Sorin's heater-cooler units during open-chest surgery, and held an advisory panel meeting last week to discuss strategies to better ensure safety of these and similar devices.
You may also be interested in...
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Allowing States To Ban Abortion Services Increases Calls For Making Birth Control Available OTC
Supreme Court’s six conservative justices say Constitution doesn’t guarantee a woman’s right to abortion services nor prohibit states from regulating or banning the services. Dissenting liberal members decry decision as erasing women’s constitutional rights.
RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.