JD Supra8h
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
aha.org10h
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 ...
TCTMD11h
FDA Issues Early Alert About Risks of Peripheral Atherectomy Device
Fractures and breakages of the helix on the Rotarex system has led to 30 serious injuries, four deaths, and 115 interventions ...
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 ...
Are smartphone diabetes devices putting lives in danger? US FDA sounds alarm
The US FDA warns users of smartphone-linked diabetes devices like CGMs and insulin pumps of potential health risks due to ...
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 ...
Hosted on MSN1d
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 ...
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 ...