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Hannah Daniel

Reporter

Hannah joined Medtech Insight from HBW Insight in August 2022 and reports on cybersecurity, patent law and other facets of medical device regulation. Hannah is passionate about the intersection of science and communication and holds a bachelor’s degree in biology from Carnegie Mellon University.

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.

Warning Letters Regulation

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.

Approvals Regulation

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.

Safety Legal Issues

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.

Cybersecurity Policy

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.

OTC Devices Sustainability

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.

Medical Device Cybersecurity
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