News

JD Supra6d
Recalled Medical Devices: How to Check If You Have One
Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
American Hospital Association7d
Recall issued by FDA for certain craniotomy kits
The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy ...
American Hospital Association5d
FDA issues most serious recall for Edwards Lifesciences cannulas
The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula ...
Fierce Biotech7d
FDA amplifies neurosurgery kit recall efforts at Medline, Integra
The FDA is amplifying an effort underway at medical device distributor Medline that aims to correct certain neurosurgery kits ...
FDA Sued Over Allegedly Defective Spinal Cord Stimulators
A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...
Juul can continue selling its tobacco and menthol e-cigarettes, FDA says
The FDA decision applies to both tobacco- and menthol-flavored versions of the reusable product, which works with ...
Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes
The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a ...
Huge drug empire uncovered after tip-offs lead to house raids
A huge drug trafficking operation has been dismantled with two people behind bars after tip-offs led to a house being raided ...
Juul can keep selling tobacco and menthol e-cigarettes, FDA decides
FDA regulators said Juul's studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping.