Hannah Daniel
Reporter
Latest From Hannah Daniel
FDA Warns Eye Care Company Conducting Unapproved Clinical Trial Of Drug-Device Product
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.
Color Additive Risk Evaluation Tool Qualified As New Medical Device Development Tool
A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.
Sterigenics Wins Second Lawsuit In Ongoing Ethylene Oxide Court Battles
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.
Exec Chat: Cybersecurity Regulations Aren’t Burdensome But ‘Best Practice’
Impero senior vice president of products Sam Heiney spoke to Medtech Insight about reframing the way medtech and healthcare organizations think about cybersecurity regulations.
FDA Should Undo Incentives For Single-Use Products, Device Reprocessing Expert Says
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.
Cybersecurity Is A ‘Team Sport:’ FDA And MITRE Update Medical Device Cybersecurity Playbook
In collaboration with FDA, MITRE published an updated playbook for medical device cybersecurity preparedness.