Forward-thinking manufacturers build native compliance protocols as a workflow, not as an afterthought—a pitfall that many ...

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, ...

Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ device issue with certain GE ...

The FDA’s CSA guidance is final. Every validation project executed the old way is time and money you won’t get back—and audit exposure you can’t afford. Here is an uncomfortable truth for quality ...

Researchers at the Icahn School of Medicine at Mount Sinai have identified a previously hidden druggable site in a cancer-related protein that could open the door toward the development of a new ...

In April 2026, Anthropic released its newest frontier model, codename Mythos, to twelve partners under a gated preview. Not general availability; the company explicitly held it back as it was ...

An early warning system for sepsis, one of the deadliest infections for hospital patients, has been approved for use by the FDA, one of the first AI-based medical tools to get clearance. The tool, ...

An early warning system for sepsis, one of the deadliest infections for hospital patients, has been approved for use by the U.S. Food and Drug Administration, one of the first AI-based medical tools ...

The July 2026 advisory review could reopen compounding pathways for peptides previously curtailed in 2023 over immunogenicity, toxicity, impurity risk, and inadequate human clinical evidence.

The FDA has accomplished one of the most important regulatory overhauls in decades by replacing the traditional Quality System Regulation (QSR) with the Quality Management System Regulation (QMSR).

All patients will be out of West Suburban Medical Center in Oak Park as the hospital blames its abrupt shutdown on a computerized billing system. On Thursday hospital signs were getting covered up, ...

Gear-obsessed editors choose every product we review. We may earn commission if you buy from a link. Why Trust Us? Here’s what you’ll learn when you read this story: The Inca quipu was a complex ...