Medscape7h
FDA Warns About Diabetes Device Smartphone Alert Settings
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...
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 ...
medtechdive5d
Troy Tazbaz, CDRH digital health leader, resigns
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.
aha.org5d
CISA, FDA warn of vulnerabilities in Contec patient monitors
The Cybersecurity and Infrastructure Security Agency and Food and Drug Administration Jan. 30 released notices warning of ...
Health Affairs6d
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.
BioPharma Dive6d
Troy Tazbaz, an FDA digital health leader, resigns
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...
JD Supra6d
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...