Category: Standards

Standards

Medtronic Stent Graft Recall Is Serious

Medtronic has recalled the Valiant Navion thoracic stent graft system due to stent fractures and endoleak concerns. But the FDA has categorized the recall as Class 1, the most critical kind.

Standards

COVID-19 Mask Study Finds Layering, Material Choice Matter

Wearing a face mask can protect yourself and others from COVID-19, but the type of material and how many fabric layers used can significantly affect exposure risk, finds a study from the Georgia Institute of Technology.

Standards

Are Hospital Silos Impeding Security?

In this article, Medigate CEO Jonathan Langer discusses how bridging the chasm between the hospital IT/security, C-suite, and biomed departments protects patients and data.

Servicing Legislation

Half of U.S. States Looking to Give Americans the Right to Repair

With the introduction of AB 221 in Nevada, 25 states across the country have considered active Right to Repair legislation so far in 2021, demonstrating the widespread appeal of the policy, advocates say.

FDA Updates

Stimdia pdSTIM System Receives FDA Breakthrough Device Designation

The Stimdia pdSTIM system is designed to facilitate weaning patients from mechanical ventilation by reconditioning the diaphragm.

Government Regulations

New Award Recognizes Improvements in Healthcare Disparities

The Joint Commission and Kaiser Permanente have come together to establish The Bernard J. Tyson Award for Excellence in Pursuing Health Care Equity.

Cybersecurity

IoT and Medical Device Cybersecurity: Standards Coming

Third-party certification body SAFE Identity is working with digital identity companies to create cybersecurity standards for medical devices, reports MSSP Alert.