Hosted on MSN1h
FDA grants breakthrough designation for Acrivon’s endometrial cancer assay
The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 ...
medtechdive18h
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 Supra2d
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.
2025 Medical Device Cybersecurity Trends: What Will Shape The Industry?
What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.
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HeartBeam submits 510(k) application to FDA for ECG software
HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram ...
Canada20d
Drug and medical device establishment licence fees
Instructions for filling out the medical device establishment licence application. Information includes a calculation chart for the required fees and related guidance documents.
Forbes21d
FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food And Trust
Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...
ScienceAlert21d
FDA Finally Outlaws Red Food Dye Banned Around The World
Outgoing US President Joe Biden's administration on Wednesday announced a ban on Red Dye No 3, a controversial food and drug coloring long known to cause cancer in animals. Decades after scientific ...