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...
QUOTED. 19 April 2021. Jeff Shuren & William Maisel
Two top officials in the US FDA’s device center are warning of delays in the agency’s review of submissions for new products that aren’t directly tied to the coronavirus pandemic.
Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021
With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.
Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval
Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.