FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Dexcom is facing scrutiny and class-action lawsuits over alleged safety and accuracy issues with its G7 monitor.

Spread across 350 acres, the facility pays emphasis on common scientific facilities (CSFs) and a state-of-the-art gamma radiation centre, which will play a key role in research, testing, and manufactu ...

"We are headed down the road of increasing development and utilization of devices to treat heart failure," Dr. William ...

Junkosha Launches Thin Wall Etched PTFE Liner in Answer to Customer Demands Developed to enable complex catheter designs, ...

Drug-releasing medical devices have revolutionized therapeutic delivery by integrating pharmacological function directly into biomedical implants. A ...

This detailed look at the collaboration driving new capabilities in ultrafast laser processing systems includes a Q&A with ...

Today's pacemakers are about the size of a small matchbox, and future models are expected to shrink even further, becoming smaller than a grain of rice. Now, these devices, depending on the model, can ...

As a wound heals, it goes through several stages: clotting to stop bleeding, immune system response, scabbing, and scarring. A wearable device called "a-Heal," designed by engineers at the University ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...