GlobalData on MSN3d
FDA tags Sentec/Percussionaire’s breathing circuit recall as Class I
The US Food and Drug Administration (FDA) has tagged a recall of breathing circuits manufactured by Sentec/Percussionaire as ...
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 ...
medtechdive9d
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 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 Supra11d
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 ...
Yahoo Finance11d
FDA labels recall of discontinued Olympus endoscope accessory as Class I
In recent years, Olympus has recalled other devices because of patient safety risks and ... In its Class I recall notice, the agency’s most serious classification, the FDA said patient exposure to a ...
Forbes14d
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
The FDA reported that in 2023, 221 medical device submissions included an ... Automation of device discovery and classification helps implement zero trust. Continuous monitoring of this and ...
The National Law Review15d
FDA Releases Draft Guidance on AI-Enabled Medical Devices
You are responsible for reading, understanding, and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy ...
dermatologyadvisor15d
FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
In December and January, the US Food and Drug Administration (FDA) approved new therapies for lung cancer, atopic dermatitis, obstructive sleep apnea (OSA), and cystic fibrosis. The FDA also added a ...
Today16d
Lay’s potato chip recall elevated to FDA’s highest-risk classification
On Jan. 27, the FDA escalated the recall to the highest risk level, Class I, which means exposure to or consumption of the product could cause “serious adverse health consequences or death.” ...