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 ...
MassDevice5h
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.
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 ...
Hosted on MSN21h
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 ...
FDA approves wearable infusion device for advanced Parkinson disease
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...
medtechdive1d
FDA labels recall of discontinued Olympus endoscope part as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
JD Supra3d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
FDA labels recall of discontinued Olympus endoscope accessory as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of the device.