aha.org4h
FDA warns of potential to miss notifications on smartphone-compatible diabetes devices
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...
Hosted on MSN7h
FDA fast tracks Bracco’s BR55 for Crohn’s disease bowel inflammation detection
Engineered to specifically act on the vascular endothelial growth factor receptor 2 (VEGFR2), BR55 (perfluorobutane/nitrogen ...
dvm3601d
FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
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, ...
Interesting Engineering2d
US FDA approves first-ever smart glasses with hearing aid for mild to moderate loss
EssilorLuxottica's Nuance Audio Glasses receive FDA clearance for OTC sales in the US, revolutionizing hearing solutions with ...
JD Supra4d
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 ...
Health Affairs7d
We Need More Robust Post-Market Surveillance For Health Care AI
The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.
Hosted on MSN9d
Six months “a very limited window” for medical device shortage flagging
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
unece14d
(UK) Proposal for the 02 Series of Amendments to UN Regulation No. 73 (Lateral Protection Devices)
ECE-TRANS-WP.29-GRSG-2025-03e.docx (application/vnd.openxmlformats-officedocument.wordprocessingml.document, 51.75 KB) ...
The Business Journals15d
Liberty human tissue bank sues FDA over regulation of umbilical cord product
Vitti Labs says the Food and Drug Administration erred in subjecting the lab's umbilical cord-derived product in a way that brings greater regulation. Liberty-based Vitti Labs, a human tissue bank ...