JD Supra3 小时
FDA Sued Over Laboratory Developed Tests Final Rule
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
GlobalData on MSN11 小时
FDA issues “high-risk” safety alert to Nuwellis blood circuit sets
Too many alarms on the AquaFlexFlow UF 500 Plus could terminate therapy, leading to hypovolemia or dehydration.
Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
JD Supra1 天
FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations ...
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
5 health care businesses that received FDA designations in 2024
South Florida's health care industry made headlines in 2024, with medical device and pharmaceutical companies announcing ...
Medical Design and Outsourcing7 天
Vision check with FDA CDRH Director Dr. Michelle Tarver
Dr. Michelle Tarver, a veteran leader at the FDA, is director of the Center for Devices and Radiological Health at a pivotal ...
FDA approves Eli Lilly’s obesity medication for obstructive sleep apnea
The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe ...
The popular weight-loss drug Zepbound can now be used to treat sleep apnea
The FDA on Friday approved Eli Lilly's weight-loss drug Zepbound as a treatment for moderate-to-severe sleep apnea and ...
FDA approves weight-loss drug Zepbound for obstructive sleep apnea
The US Food and Drug Administration on Friday approved the first prescription medicine for obstructive sleep apnea: the ...