Content oversight and quality assurance provided by Studio 1847 Health care-associated infections pose a persistent and tremendous threat to patient safety. According to the Centers for Disease ...

Level Zero Health, a female-founded medical device startup that's aiming to break new ground by developing a device for ...

Ms. Geffner-Atiya holds a Bachelor of Science degree from the State University of New York at Brockport. In her new role, she will oversee regulatory compliance, quality assurance, and global ...

The cuts hit the FDA's medical device center particularly hard, including reviewers and experts on AI-enabled medical ...

Lynlee Brown, a global trade partner at EY, outlined several strategies for device manufacturers to offset fast-moving ...

Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Neonav electrocardiogram (ECG) tip location system, a central venous access device (CVAD) placement platform developed by ...

The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering. This is an excellent introduction from leading experts in the ...

The Ministry of Food and Drug Safety noted on the 11th that it inspected cases of drug, quasi-drug, and medical device distribution through overseas ... consumer harm could arise from misuse, urging ...

Medical devices that use ML, in part or in whole, to achieve their intended medical purpose are known as machine learning-enabled medical devices (MLMD). "Medical purpose" refers to parts (a) through ...

The backdoor on Contec CMS8000 patient-monitoring devices could allow an IP address at an unnamed university to remotely download and execute unverified files, according to CISA.