Latest From Hannah Daniel
The FDA sent a warning letter to Arbor Center for EyeCare for failing to submit an IND before beginning a trial of a novel drug-device combination product.
A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.
In the second trial over Sterigenics’ ethylene oxide plant emissions, the Cook County, IL jury found Stergiencs not liable for cancer in a woman who lived near the plant.
Impero senior vice president of products Sam Heiney spoke to Medtech Insight about reframing the way medtech and healthcare organizations think about cybersecurity regulations.
Medtech Insight sat down with Dan Vukelich, president and CEO of the Association of Medical Device Reprocessors, to discuss the need for sustainable alternatives to limit waste from medical devices.
In collaboration with FDA, MITRE published an updated playbook for medical device cybersecurity preparedness.