MassDevice7h
Medline has a Class I arterial catheter recall
The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall.
JD Supra23h
BIS Increases Export Controls on Key Biotech Equipment
BIS issued an Interim Final Rule that amends the Export Administration Regulation (EAR) to address dual use export ...
Cookies Recall Update as FDA Sets Risk Level
The U.S. Food and Drug Administration (FDA) has given its second most serious risk level, Class II, to a product from D. Coluccio & Sons. The recalled product is a 300 gram pack of chocolate chip ...
FDA clears migraine device for children as young as 8
A device long used by adults to manage migraines was now available for children as young as eight years old, offering new ...
U.S. Biomedical Leadership Threatened By NIH Licensing Guidelines
New licensing Guidelines issued by the National Institutes of Health at the end of the Biden Administration could harm ...
Medscape10h
New Recommendations for Cardiac Devices
The new ACC and AHA criteria for cardiac devices emphasize more risk stratification, reflecting advances in the field in ...
Hosted on MSN23h
FDA grants orphan drug status to Arbor Biotechnologies’ PH1
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation (RPDD) to Arbor Biotechnologies' gene editing therapeutic, ABO-101, to treat ...